CLEAR Model for Predicting Ventilatory Liberation in Severe COPD (CLEAR)
6 maja 2026 zaktualizowane przez: Ahmad Shaddad, Assiut University
Prospective Development and Validation of the CLEAR Model for Predicting Ventilatory Liberation in Severe Chronic Obstructive Pulmonary Disease: A Cohort Study
This prospective observational cohort study aims to prospectively evaluate and validate the Clinical Load, Exchange, Ability of Respiration, and Reserve (CLEAR) model for predicting sustained ventilatory liberation in patients with severe chronic obstructive pulmonary disease (COPD) receiving invasive mechanical ventilation (MV) or non-invasive ventilation (NIV).
Two parallel cohorts will be studied: CLEAR-MV for patients undergoing spontaneous breathing trials (SBT) and CLEAR-NIV for patients undergoing NIV withdrawal trials.
The model integrates diaphragm ultrasound evaluating diaphragm thickening fraction (DTF), ventilatory load indices including the rapid shallow breathing index (RSBI) or Clinical Load Index (CLI), gas exchange parameters including Potential of Hydrogen (pH), partial pressure of carbon dioxide (PaCO₂), and its change over time (ΔPaCO₂) combined as the Gas Exchange Index (GEI), and peripheral muscle reserve assessing rectus femoris (RF) and vastus intermedius (VI) thickness.
The primary outcome is successful liberation from ventilatory support within 72 hours.
Secondary outcomes include ventilatory failure within 7 days, ventilator- or NIV-free days at 28 days, and time-fixed 90-day clinical outcomes including all-cause mortality, sustained ventilatory independence, and rehospitalization for respiratory failure.
Model performance will be evaluated using discrimination (area under the receiver operating characteristic curve), calibration (calibration intercept and slope), and clinical utility (decision curve analysis and net benefit) and compared with prespecified established ventilatory indices, including the Rapid Shallow Breathing Index (RSBI) and Integrative Weaning Index (IWI) in the invasive mechanical ventilation cohort, and the Heart rate, Acidosis, Consciousness, Oxygenation, and Respiratory rate (HACOR) score and the ratio of peripheral oxygen saturation to fraction of inspired oxygen divided by respiratory rate (ROX) index in the non-invasive ventilation cohort.
Przegląd badań
Status
Rekrutacyjny
Szczegółowy opis
This study is a prospective, dual-cohort observational investigation designed to develop and internally validate the Clinical Load, Exchange, Ability of Respiration, and Reserve (CLEAR) model for predicting sustained liberation from ventilatory support in patients with severe chronic obstructive pulmonary disease (COPD). The study includes two parallel cohorts based on the mode of ventilatory support: an invasive mechanical ventilation (MV) cohort (CLEAR-MV) and a non-invasive ventilation (NIV) cohort (CLEAR-NIV). The model structure and domain composition are prespecified; parameter estimation involves applying a fixed framework rather than exploratory model development.
In this study, "development" refers exclusively to parameter estimation within a prespecified and structurally locked model framework. The model structure, domain composition, and variable definitions were defined prior to outcome analysis and are not subject to modification. No variable selection, structural changes, or data-driven model building procedures will be performed. Validation refers to performance assessment in an independent cohort using the same fixed model structure.
Eligible adult patients with COPD admitted to the intensive care unit (ICU) and receiving MV or NIV for acute respiratory failure will be enrolled. Patients will be assessed at the time of readiness for ventilatory withdrawal: during a spontaneous breathing trial (SBT) in the MV cohort and during a structured withdrawal or low-support trial in the NIV cohort.
The CLEAR framework comprises four domains: Clinical Load (L), Exchange (E), Ability of Respiration (A), and Reserve (R). The Ability domain integrates diaphragm contractility assessed by ultrasound-derived diaphragm thickening fraction (DTF) and functional endurance during SBT or NIV withdrawal trials. The Load domain is assessed using the rapid shallow breathing index (RSBI) in the MV cohort and a composite Clinical Load Index (CLI) in the NIV cohort, incorporating respiratory rate, work of breathing, dyspnea, and ventilatory support requirements. The Exchange domain is based on arterial blood gas parameters, including pH, partial pressure of carbon dioxide (PaCO₂), and the change in PaCO₂ (ΔPaCO₂), combined into a Gas Exchange Index (GEI) in the NIV cohort and used as a safety assessment in the MV cohort. The Reserve domain reflects systemic muscle capacity and is assessed using ultrasound-derived thicknesses of the Rectus Femoris (RF) and vastus intermedius (VI).
The primary outcome is successful liberation from ventilatory support within 72 hours, defined as the absence of reintubation in the MV cohort and the absence of NIV restart or escalation to invasive ventilation in the NIV cohort. Secondary outcomes include ventilatory failure within 7 days, ventilator- or NIV-free days at 28 days, and time-fixed 90-day outcomes including all-cause mortality, sustained ventilatory independence, and rehospitalization for respiratory failure.
Comparative analyses will be performed against prespecified established indices. In the MV cohort, CLEAR-MV will be compared with the Rapid Shallow Breathing Index (RSBI) and, where available, the Integrative Weaning Index (IWI), which combines static compliance, arterial oxygen saturation, and RSBI. In the NIV cohort, CLEAR-NIV will be compared with the Heart rate, Acidosis, Consciousness, Oxygenation, and Respiratory rate (HACOR) score and the ratio of peripheral oxygen saturation to fraction of inspired oxygen divided by respiratory rate (ROX) index.
Model performance will be evaluated using discrimination (area under the receiver operating characteristic curve), calibration (calibration intercept and slope), and clinical utility (decision curve analysis and net benefit).
Separate multivariable logistic regression models will be estimated within a derivation cohort and evaluated in a validation cohort according to the prespecified CLEAR framework. Model performance will be evaluated directly within the study cohorts, without resampling-based internal validation. The independent and incremental contribution of the Clinical Load Index (CLI) and Gas Exchange Index (GEI) will be specifically assessed. Additional prespecified analyses will include domain correlation, model ablation, and prespecified ventilatory support state-transition analysis if longitudinal support-state data are available. No distinction exists between model development and structure specification; all structural elements are fixed prior to analysis.
Model outputs will be translated into predefined bedside scoring representations consistent with the prespecified framework.
The CLEAR framework and its component indices (Clinical Load Index and Gas Exchange Index) were prospectively defined and structurally locked before outcome analysis in an open-access research data repository (Zenodo), Digital Object Identifiers (DOIs):
10.5281/zenodo.19929675, 10.5281/zenodo.19931693, 10.5281/zenodo.19932153).
Typ studiów
Obserwacyjny
Zapisy (Szacowany)
400
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Ahmad M. Shaddad, MD
- Numer telefonu: +201111171930
- E-mail: shaddad_ahmad@aun.edu.eg
Lokalizacje studiów
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-
Assuit Egypt
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Asyut, Assuit Egypt, Egipt, 71515
- Rekrutacyjny
- Assuit Univeristy
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Kontakt:
- Ahmad M. Shaddad, MD
- Numer telefonu: +201111171930
- E-mail: shaddad_ahmad@aun.edu.eg
-
Kontakt:
- Ahmad Shaddad
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Adult patients aged ≥40 years with confirmed or clinically diagnosed chronic obstructive pulmonary disease (COPD) admitted to the intensive care unit with acute respiratory failure requiring ventilatory support will be enrolled.
Patients will be classified into two prospective cohorts according to the mode of ventilatory support received as part of routine clinical care: an invasive mechanical ventilation cohort (CLEAR-MV) and a non-invasive ventilation cohort (CLEAR-NIV).
Enrollment will occur at the time patients are considered clinically ready for ventilatory withdrawal assessment, either during a spontaneous breathing trial in the MV cohort or during a structured NIV withdrawal or low-support trial in the NIV cohort.
Opis
Inclusion Criteria:
- Age ≥40 years
- Confirmed or clinically diagnosed chronic obstructive pulmonary disease (COPD) based on prior spirometry or consistent clinical history
- Admission to the intensive care unit (ICU) with acute respiratory failure requiring ventilatory support
- Receiving either:
Invasive mechanical ventilation (MV), or Non-invasive ventilation (NIV)
-Considered clinically ready for ventilatory withdrawal: Undergoing spontaneous breathing trial (SBT) in the MV cohort Undergoing structured withdrawal or low-support trial in the NIV cohort
Exclusion Criteria:
- Age <40 years
- Primary diagnosis other than COPD driving respiratory failure (e.g., isolated pneumonia, cardiogenic pulmonary edema without COPD exacerbation)
- Known neuromuscular disease affecting respiratory muscle function
- Significant chest wall deformity or restrictive thoracic disorder affecting ventilatory mechanics
- Presence of tracheostomy at baseline
- Hemodynamic instability requiring high-dose vasopressors at the time of assessment
- Inability to perform a diaphragm or muscle ultrasound (e.g., poor acoustic window, extensive dressings)
- Reduced level of consciousness precluding valid clinical assessment (outside expected NIV cohort context)
- Refusal of consent by patient or legal representative
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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CLEAR-MV
Adults with severe chronic obstructive pulmonary disease (COPD) receiving invasive mechanical ventilation and undergoing spontaneous breathing trial (SBT) assessment for ventilatory liberation.
Patients are evaluated using the CLEAR domains (Load, Exchange, Ability, and Reserve) at the time of SBT.
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CLEAR-NIV
Adults with severe chronic obstructive pulmonary disease (COPD) receiving non-invasive ventilation (NIV) and undergoing structured withdrawal or low-support trial assessment for ventilatory liberation.
Patients are evaluated using the CLEAR domains (Load, Exchange, Ability, and Reserve) at the time of NIV withdrawal.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Successful Ventilatory Liberation Within 72 Hours
Ramy czasowe: 72 hours
|
Successful liberation from ventilatory support defined as absence of ventilatory failure within 72 hours.
In CLEAR-MV, this is defined as no reintubation within 72 hours following extubation.
In CLEAR-NIV, this is defined as no restart of non-invasive ventilation or escalation to invasive mechanical ventilation within 72 hours following withdrawal.
The Clinical Load, Exchange, Ability, and Reserve (CLEAR) model is a novel multidomain ventilatory assessment framework undergoing prospective derivation and validation in this study to estimate the probability of successful ventilatory liberation and related clinical outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
Higher CLEAR model performance values are anticipated to correlate with improved prediction of successful ventilatory liberation and favorable clinical outcomes.
Unit of Measure: Percentage of participants.
|
72 hours
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Ventilatory Failure Within 7 Days
Ramy czasowe: 7 days
|
Failure of ventilatory liberation defined as reintubation in the invasive mechanical ventilation cohort or need for non-invasive ventilation restart or escalation to invasive ventilation within 7 days.
Unit of Measure: Percentage of participants.
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7 days
|
|
Ventilator-Free Days at 28 Days
Ramy czasowe: 28 days
|
Number of days alive and free from invasive ventilatory support within the first 28 days.
Patients who die within 28 days are assigned zero free days.
Unit of Measure: Days.
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28 days
|
|
90-Day All-Cause Mortality
Ramy czasowe: 90 days
|
All-cause mortality occurring within 90 days following ventilatory assessment.
Unit of Measure: Percentage of participants.
|
90 days
|
|
Sustained Ventilatory Independence at 90 Days
Ramy czasowe: 90 days
|
Proportion of patients remaining free from invasive or non-invasive ventilatory support within 90 days following initial liberation without need for reinitiation of ventilatory support.
Unit of Measure: Percentage of participants.
|
90 days
|
|
Rehospitalization for Respiratory Failure at 90 Days
Ramy czasowe: 90 days
|
Hospital readmission due to respiratory failure requiring ventilatory support within 90 days.
Unit of Measure: Percentage of participants.
|
90 days
|
|
Non-invasive Ventilation (NIV) Free Days at 28 Days
Ramy czasowe: 28 days
|
Number of days alive and free from non-invasive ventilatory support within the first 28 days.
Patients who die within 28 days are assigned zero free days.
Unit of Measure: Days.
|
28 days
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Predictive Performance of the Clinical Load Index (CLI) for Ventilatory Liberation Within 72 Hours
Ramy czasowe: 72 hours
|
Evaluation of the discrimination performance of the Clinical Load Index (CLI) for prediction of successful ventilatory liberation within 72 hours using area under the receiver operating characteristic curve analysis.
The Clinical Load Index (CLI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with increased clinical load and reduced probability of successful ventilatory liberation.
Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale).
Higher values indicate better discrimination performance.
|
72 hours
|
|
Predictive Performance of the Gas Exchange Index (GEI) for Ventilatory Liberation Within 72 Hours
Ramy czasowe: 72 hours
|
Evaluation of the discrimination performance of the Gas Exchange Index (GEI), based on pH, partial pressure of carbon dioxide (PaCO₂), and change in PaCO₂ (ΔPaCO₂), for prediction of successful ventilatory liberation within 72 hours using area under the receiver operating characteristic curve analysis.
The Gas Exchange Index (GEI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with worsening gas exchange impairment and increased risk of ventilatory liberation failure.
Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale).
Higher values indicate better discrimination performance.
|
72 hours
|
|
Incremental Discrimination Performance of the Clinical Load Index (CLI) for Ventilatory Liberation Within 72 Hours
Ramy czasowe: 72 hours
|
Assessment of the incremental contribution of the Clinical Load Index (CLI) to the CLEAR model by evaluating changes in discrimination performance for prediction of successful ventilatory liberation within 72 hours compared with baseline models without CLI.
The Clinical Load Index (CLI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with increased clinical load and reduced probability of successful ventilatory liberation.
Unit of Measure: Area under the receiver operating characteristic curve difference (0-1 scale).
Higher values indicate greater incremental discrimination improvement.
|
72 hours
|
|
Association Between Clinical Load Index (CLI) Categories and Ventilatory Liberation Success
Ramy czasowe: 72 hours
|
Assessment of the association between predefined Clinical Load Index (CLI) categories and successful ventilatory liberation within 72 hours.
The Clinical Load Index (CLI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with increased clinical load and reduced probability of successful ventilatory liberation.
Unit of Measure: Percentage of participants.
|
72 hours
|
|
Discrimination Performance of CLEAR-MV Compared With Rapid Shallow Breathing Index (RSBI)
Ramy czasowe: 72 hours
|
Assessment of discrimination performance using area under the receiver operating characteristic curve for prediction of ventilatory liberation within 72 hours.
The Rapid Shallow Breathing Index (RSBI) is calculated as respiratory rate divided by tidal volume, typically ranging from 0 to approximately 200 breaths/min/L, with higher values indicating greater risk of ventilatory liberation failure.
CLEAR-MV is a novel score undergoing derivation and validation in invasively ventilated patients to estimate probability of successful ventilatory liberation and related outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
Higher CLEAR-MV model performance values are anticipated to correlate with improved prediction of successful ventilatory liberation and favorable clinical outcomes.
Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale).
Higher values indicate better discrimination performance.
|
72 hours
|
|
Correlation Analysis Between CLEAR Domains and Ventilatory Liberation Outcomes at 72 Hours
Ramy czasowe: 72 hours
|
Assessment of correlations between CLEAR domain scores and ventilatory liberation outcomes at 72 hours using correlation coefficient analysis.
The Clinical Load, Exchange, Ability, and Reserve (CLEAR) model is a novel multidomain ventilatory assessment framework undergoing prospective derivation and validation in this study.
The model integrates physiological, respiratory, and functional domains to estimate the probability of successful ventilatory liberation and related clinical outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
It is anticipated that higher calculated CLEAR model performance values will correlate with improved prediction of successful ventilatory liberation and clinical outcomes.
Unit of Measure: Correlation coefficients (-1 to +1 scale).
Values farther from 0 indicate stronger correlation strength.
|
72 hours
|
|
Incremental Discrimination Performance of the Gas Exchange Index (GEI) for Ventilatory Liberation Within 72 Hours
Ramy czasowe: 72 hours
|
Assessment of the incremental contribution of the Gas Exchange Index (GEI) to the CLEAR model by evaluating changes in discrimination performance for prediction of successful ventilatory liberation within 72 hours compared with baseline models without GEI.
The Gas Exchange Index (GEI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with worsening gas exchange impairment and increased risk of ventilatory liberation failure.
Unit of Measure: Area under the receiver operating characteristic curve difference (0-1 scale).
Higher values indicate greater incremental discrimination improvement.
|
72 hours
|
|
Incremental Calibration Performance of the Clinical Load Index (CLI) for Ventilatory Liberation Within 72 Hours
Ramy czasowe: 72 hours
|
Assessment of the incremental contribution of the Clinical Load Index (CLI) to the CLEAR model by evaluating changes in calibration performance for prediction of successful ventilatory liberation within 72 hours compared with baseline models without CLI.
Calibration performance will be assessed using calibration intercept and calibration slope.
The Clinical Load Index (CLI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with increased clinical load and reduced probability of successful ventilatory liberation.
Unit of Measure: Unitless calibration coefficients.
Calibration intercept values closer to 0 indicate better agreement between predicted and observed outcomes, while calibration slope values closer to 1 indicate optimal calibration performance.
|
72 hours
|
|
Incremental Calibration Performance of the Gas Exchange Index (GEI) for Ventilatory Liberation Within 72 Hours
Ramy czasowe: 72 hours
|
Assessment of the incremental contribution of the Gas Exchange Index (GEI) to the CLEAR model by evaluating changes in calibration performance for prediction of successful ventilatory liberation within 72 hours compared with baseline models without GEI.
Calibration performance will be assessed using calibration intercept and calibration slope.
The Gas Exchange Index (GEI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with worsening gas exchange impairment and increased risk of ventilatory liberation failure.
Unit of Measure: Unitless calibration coefficients.
Calibration intercept values closer to 0 indicate better agreement between predicted and observed outcomes, while calibration slope values closer to 1 indicate optimal calibration performance.
|
72 hours
|
|
Association Between Gas Exchange Index (GEI) Categories and Ventilatory Liberation Success
Ramy czasowe: 72 hours
|
Assessment of the association between predefined Gas Exchange Index (GEI) categories and successful ventilatory liberation within 72 hours.
The Gas Exchange Index (GEI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with worsening gas exchange impairment and increased risk of ventilatory liberation failure.
Unit of Measure: Percentage of participants.
|
72 hours
|
|
Association Between Clinical Load Index (CLI) Categories and 90-Day All-Cause Mortality
Ramy czasowe: 90 days
|
Assessment of the association between predefined Clinical Load Index (CLI) categories and 90-day all-cause mortality.
The Clinical Load Index (CLI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with increased clinical load and reduced probability of successful ventilatory liberation.
Unit of Measure: Percentage of participants.
|
90 days
|
|
Association Between Gas Exchange Index (GEI) Categories and 90-Day All-Cause Mortality
Ramy czasowe: 90 days
|
Assessment of the association between predefined Gas Exchange Index (GEI) categories and 90-day all-cause mortality.
The Gas Exchange Index (GEI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with worsening gas exchange impairment and increased risk of ventilatory liberation failure.
Unit of Measure: Percentage of participants.
|
90 days
|
|
Discrimination Performance of CLEAR-MV Compared With Integrative Weaning Index (IWI)
Ramy czasowe: 72 hours
|
Assessment of discrimination performance using area under the receiver operating characteristic curve for prediction of ventilatory liberation within 72 hours.
The Integrative Weaning Index (IWI) is a continuous scale typically ranging from near 0 to above 100, with higher values indicating greater probability of successful ventilatory liberation.
CLEAR-MV is a novel multidomain ventilatory assessment framework undergoing prospective derivation and validation in invasively ventilated patients to estimate probability of successful ventilatory liberation and related clinical outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
Higher CLEAR-MV model performance values are anticipated to correlate with improved prediction of successful ventilatory liberation and favorable clinical outcomes.
Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale).
Higher values indicate better discrimination performance.
|
72 hours
|
|
Discrimination Performance of CLEAR-NIV Compared With HACOR Score
Ramy czasowe: 72 hours
|
Assessment of discrimination performance using area under the receiver operating characteristic curve for prediction of ventilatory liberation within 72 hours.
The Heart rate, Acidosis, Consciousness, Oxygenation, and Respiratory rate (HACOR) score ranges from 0 to 25, with higher scores indicating greater risk of non-invasive ventilation failure.
CLEAR-NIV is a novel multidomain ventilatory assessment framework undergoing derivation and validation in non-invasively ventilated patients to estimate probability of successful ventilatory liberation and related clinical outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
Higher CLEAR-NIV model performance values are anticipated to correlate with improved prediction of successful ventilatory liberation and favorable clinical outcomes.
Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale).
Higher values indicate better discrimination performance.
|
72 hours
|
|
Discrimination Performance of CLEAR-NIV Compared With ROX Index
Ramy czasowe: 72 hours
|
Assessment of discrimination performance using area under the receiver operating characteristic curve for prediction of ventilatory liberation within 72 hours.
The ratio of oxygen saturation to fraction of inspired oxygen divided by respiratory rate (ROX) index typically ranges from approximately 2 to 20, with higher values indicating greater probability of successful non-invasive ventilatory support outcomes.
CLEAR-NIV is a novel score undergoing derivation and validation in non-invasively ventilated patients to estimate probability of successful ventilatory liberation and related outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
Higher CLEAR-NIV performance values are anticipated to correlate with improved prediction of successful ventilatory liberation and favorable clinical outcomes.
Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale).
Higher values indicate better discrimination performance.
|
72 hours
|
|
Calibration Performance of CLEAR-MV
Ramy czasowe: 72 hours
|
Assessment of calibration performance using calibration intercept and calibration slope.
The Clinical Load, Exchange, Ability, and Reserve for Mechanical Ventilation (CLEAR-MV) model is a novel multidomain ventilatory assessment framework undergoing prospective derivation and validation in this study for patients receiving invasive mechanical ventilation.
The model integrates physiological, respiratory, and functional domains to estimate the probability of successful ventilatory liberation and related clinical outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
It is anticipated that higher calculated CLEAR-MV model performance values will correlate with improved prediction of successful ventilatory liberation and favorable clinical outcomes.
Unit of Measure: Unitless calibration coefficients.
Calibration intercept values closer to 0 and calibration slope values closer to 1 indicate better calibration performance.
|
72 hours
|
|
Calibration Performance of CLEAR-NIV
Ramy czasowe: 72 hours
|
Assessment of calibration performance using calibration intercept and calibration slope.
The Clinical Load, Exchange, Ability, and Reserve for Non-Invasive Ventilation (CLEAR-NIV) model is a novel multidomain ventilatory assessment framework undergoing prospective derivation and validation in this study for patients receiving non-invasive ventilatory support.
The model integrates physiological, respiratory, and functional domains to estimate the probability of successful ventilatory liberation and related clinical outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
It is anticipated that higher calculated CLEAR-NIV model performance values will correlate with improved prediction of successful ventilatory liberation and favorable clinical outcomes.
Unit of Measure: Unitless calibration coefficients.
Calibration intercept values closer to 0 and calibration slope values closer to 1 indicate better calibration performance.
|
72 hours
|
|
Clinical Utility of CLEAR-MV
Ramy czasowe: 72 hours
|
Assessment of clinical utility of the CLEAR-MV model using decision curve analysis and net benefit across clinically relevant threshold probabilities for prediction of successful ventilatory liberation.
The Clinical Load, Exchange, Ability, and Reserve for Mechanical Ventilation (CLEAR-MV) model is a novel multidomain ventilatory assessment framework undergoing prospective derivation and validation in this study for patients receiving invasive mechanical ventilation.
The model integrates physiological, respiratory, and functional domains to estimate the probability of successful ventilatory liberation and related clinical outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
It is anticipated that higher calculated CLEAR-MV model performance values will correlate with improved prediction of successful ventilatory liberation and favorable clinical outcomes.
Unit of Measure: Net benefit (unitless).
|
72 hours
|
|
Clinical Utility of CLEAR-NIV
Ramy czasowe: 72 hours
|
Assessment of clinical utility of the CLEAR-NIV model using decision curve analysis and net benefit across clinically relevant threshold probabilities for prediction of successful ventilatory liberation.
The Clinical Load, Exchange, Ability, and Reserve for Non-Invasive Ventilation (CLEAR-NIV) model is a novel multidomain ventilatory assessment framework undergoing prospective derivation and validation in this study for patients receiving non-invasive ventilatory support.
The model integrates physiological, respiratory, and functional domains to estimate the probability of successful ventilatory liberation and related clinical outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
It is anticipated that higher calculated CLEAR-NIV model performance values will correlate with improved prediction of successful ventilatory liberation and favorable clinical outcomes.
Unit of Measure: Net benefit (unitless).
|
72 hours
|
|
Predictive Performance of the Clinical Load Index (CLI) for 90-Day All-Cause Mortality
Ramy czasowe: 90 days
|
Evaluation of the discrimination performance of the Clinical Load Index (CLI) for prediction of 90-day all-cause mortality using area under the receiver operating characteristic curve analysis.
The Clinical Load Index (CLI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with increased clinical load and reduced probability of successful ventilatory liberation.
Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale).
Higher values indicate better discrimination performance.
|
90 days
|
|
Predictive Performance of the Gas Exchange Index (GEI) for 90-Day All-Cause Mortality
Ramy czasowe: 90 days
|
Evaluation of the discrimination performance of the Gas Exchange Index (GEI), based on pH, partial pressure of carbon dioxide (PaCO₂), and change in PaCO₂ (ΔPaCO₂), for prediction of 90-day all-cause mortality using area under the receiver operating characteristic curve analysis.
The Gas Exchange Index (GEI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with worsening gas exchange impairment and increased risk of ventilatory liberation failure.
Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale).
Higher values indicate better discrimination performance.
|
90 days
|
|
Regression-Based Contribution Analysis of CLEAR Domains for Successful Ventilatory Liberation at 72 Hours
Ramy czasowe: 72 hours
|
Assessment of the contribution of individual CLEAR domains to prediction of successful ventilatory liberation at 72 hours using regression coefficient analysis.
The Clinical Load, Exchange, Ability, and Reserve (CLEAR) framework consists of two parallel ventilatory assessment models: CLEAR-MV for invasive mechanical ventilation and CLEAR-NIV for non-invasive ventilatory support.
The models are novel multidomain frameworks undergoing prospective derivation and validation in this study and integrate physiological, respiratory, and functional domains to estimate the probability of successful ventilatory liberation and related clinical outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
It is anticipated that higher calculated CLEAR model performance values will correlate with improved prediction of successful ventilatory liberation and favorable clinical outcomes.
Unit of Measure: Regression coefficients (unitless).
|
72 hours
|
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Ablation Analysis of CLEAR Model Components for Successful Ventilatory Liberation at 72 Hours
Ramy czasowe: 72 hours
|
Assessment of changes in predictive discrimination performance for successful ventilatory liberation at 72 hours following sequential removal of CLEAR model domains and components.
The Clinical Load, Exchange, Ability, and Reserve (CLEAR) framework consists of two parallel multidomain ventilatory assessment models: CLEAR-MV for invasive mechanical ventilation and CLEAR-NIV for non-invasive ventilatory support undergoing derivation and validation to estimate probability of successful ventilatory liberation and related clinical outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
Higher CLEAR model performance values are anticipated to correlate with improved prediction of successful ventilatory liberation and favorable clinical outcomes.
Unit of Measure: Area under the receiver operating characteristic curve difference (0-1 scale).
Higher values indicate greater change in discrimination performance following model component removal.
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72 hours
|
|
Ventilatory Support State-Transition Analysis
Ramy czasowe: Baseline through 90-day follow-up
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Assessment of transition patterns between invasive mechanical ventilation, non-invasive ventilation, ventilatory liberation, ventilatory support restart or escalation, discharge, and death using transition probability analysis and graphical state-flow methods.
Unit of Measure: Transition probabilities.
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Baseline through 90-day follow-up
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Association Between Clinical Load Index (CLI) Categories and Sustained Ventilatory Independence at 90 Days
Ramy czasowe: 90 days
|
Assessment of the association between predefined Clinical Load Index (CLI) categories and sustained ventilatory independence within 90 days.
The Clinical Load Index (CLI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with increased clinical load and reduced probability of successful ventilatory liberation.
Unit of Measure: Percentage of participants.
|
90 days
|
|
Association Between Gas Exchange Index (GEI) Categories and Sustained Ventilatory Independence at 90 Days
Ramy czasowe: 90 days
|
Assessment of the association between predefined Gas Exchange Index (GEI) categories and sustained ventilatory independence within 90 days.
The Gas Exchange Index (GEI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with worsening gas exchange impairment and increased risk of ventilatory liberation failure.
Unit of Measure: Percentage of participants.
|
90 days
|
|
Incremental Discrimination Performance of the Clinical Load Index (CLI) for 90-Day All-Cause Mortality
Ramy czasowe: 90 days
|
Assessment of the incremental contribution of the Clinical Load Index (CLI) to the CLEAR model by evaluating changes in discrimination performance for prediction of 90-day all-cause mortality compared with baseline models without CLI.
The Clinical Load Index (CLI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with increased clinical load and reduced probability of successful ventilatory liberation.
Unit of Measure: Area under the receiver operating characteristic curve difference (0-1 scale).
Higher values indicate greater incremental discrimination improvement.
|
90 days
|
|
Incremental Discrimination Performance of the Gas Exchange Index (GEI) for 90-Day All-Cause Mortality
Ramy czasowe: 90 days
|
Assessment of the incremental contribution of the Gas Exchange Index (GEI) to the CLEAR model by evaluating changes in discrimination performance for prediction of 90-day all-cause mortality compared with baseline models without GEI.
The Gas Exchange Index (GEI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with worsening gas exchange impairment and increased risk of ventilatory liberation failure.
Unit of Measure: Area under the receiver operating characteristic curve difference (0-1 scale).
Higher values indicate greater incremental discrimination improvement.
|
90 days
|
|
Incremental Calibration Performance of the Clinical Load Index (CLI) for 90-Day All-Cause Mortality
Ramy czasowe: 90 days
|
Assessment of the incremental contribution of the Clinical Load Index (CLI) to the CLEAR model by evaluating changes in calibration performance for prediction of 90-day all-cause mortality compared with baseline models without CLI.
Calibration performance will be assessed using calibration intercept and calibration slope.
The Clinical Load Index (CLI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with increased clinical load and reduced probability of successful ventilatory liberation.
Unit of Measure: Unitless calibration coefficients.
Calibration intercept values closer to 0 indicate better agreement between predicted and observed outcomes, while calibration slope values closer to 1 indicate optimal calibration performance.
|
90 days
|
|
Incremental Calibration Performance of the Gas Exchange Index (GEI) for 90-Day All-Cause Mortality
Ramy czasowe: 90 days
|
Assessment of the incremental contribution of the Gas Exchange Index (GEI) to the CLEAR model by evaluating changes in calibration performance for prediction of 90-day all-cause mortality compared with baseline models without GEI.
Calibration performance will be assessed using calibration intercept and calibration slope.
The Gas Exchange Index (GEI) is a novel composite index undergoing initial derivation and validation in this study.
Specific minimum and maximum score ranges and bedside threshold values have not yet been established.
It is anticipated that higher calculated values will correlate with worsening gas exchange impairment and increased risk of ventilatory liberation failure.
Unit of Measure: Unitless calibration coefficients.
Calibration intercept values closer to 0 indicate better agreement between predicted and observed outcomes, while calibration slope values closer to 1 indicate optimal calibration performance.
|
90 days
|
|
Correlation Analysis Between CLEAR Domains and 90-Day All-Cause Mortality
Ramy czasowe: 90 days
|
Assessment of correlations between CLEAR domain scores and 90-day all-cause mortality using correlation coefficient analysis.
The Clinical Load, Exchange, Ability, and Reserve (CLEAR) framework consists of two parallel multidomain ventilatory assessment models: CLEAR-MV for invasive mechanical ventilation and CLEAR-NIV for non-invasive ventilatory support.
The models are undergoing prospective derivation and validation to estimate probability of successful ventilatory liberation and related clinical outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
Higher CLEAR model performance values are anticipated to correlate with improved prediction of successful ventilatory liberation and favorable clinical outcomes.
Unit of Measure: Correlation coefficients (-1 to +1 scale).
Values farther from 0 indicate stronger correlation strength.
|
90 days
|
|
Regression-Based Contribution Analysis of CLEAR Domains for 90-Day All-Cause Mortality
Ramy czasowe: 90 days
|
Assessment of the contribution of individual CLEAR domains to prediction of 90-day all-cause mortality using regression coefficient analysis.
The Clinical Load, Exchange, Ability, and Reserve (CLEAR) framework consists of two parallel ventilatory assessment models: CLEAR-MV for invasive mechanical ventilation and CLEAR-NIV for non-invasive ventilatory support.
The models are novel multidomain frameworks undergoing prospective derivation and validation in this study and integrate physiological, respiratory, and functional domains to estimate the probability of successful ventilatory liberation and related clinical outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
It is anticipated that higher calculated CLEAR model performance values will correlate with improved prediction of successful ventilatory liberation and favorable clinical outcomes.
Unit of Measure: Regression coefficients (unitless).
|
90 days
|
|
Ablation Analysis of CLEAR Model Components for 90-Day All-Cause Mortality
Ramy czasowe: 90 days
|
Assessment of changes in predictive discrimination performance for 90-day all-cause mortality following sequential removal of CLEAR model domains and components.
The Clinical Load, Exchange, Ability, and Reserve (CLEAR) framework consists of two parallel multidomain ventilatory assessment models: CLEAR-MV for invasive mechanical ventilation and CLEAR-NIV for non-invasive ventilatory support.
The models are undergoing prospective derivation and validation to estimate probability of successful ventilatory liberation and related clinical outcomes.
Specific bedside thresholds and operational score ranges have not yet been established.
Higher CLEAR model performance values are anticipated to correlate with improved prediction of successful ventilatory liberation and favorable clinical outcomes.
Unit of Measure: Area under the receiver operating characteristic curve difference (0-1 scale).
Higher values indicate greater change in discrimination performance following model component removal.
|
90 days
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Aliae A. Hussien, MD, Assiut University
- Główny śledczy: Ahmad M. Shaddad, MD, Assiut University
- Główny śledczy: Maiada K. Hashem, MD, Assiut University
- Główny śledczy: Abdekrahman M. Korany, MBBS, Assiut University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
29 kwietnia 2026
Zakończenie podstawowe (Szacowany)
1 kwietnia 2027
Ukończenie studiów (Szacowany)
1 sierpnia 2027
Daty rejestracji na studia
Pierwszy przesłany
1 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
6 maja 2026
Pierwszy wysłany (Rzeczywisty)
11 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
11 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
6 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2026-12-5
- 10.17605/OSF.IO/A42U5 (Identyfikator rejestru: Open Science Framework (OSF))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
De-identified individual participant data (IPD) underlying the results reported in this study (including the data dictionary and statistical analysis code) will be made available upon reasonable request to qualified researchers.
Data will be shared under a formal data use agreement after approval by the principal investigator and the institutional ethics committee of Assiut University.
All shared datasets will be de-identified in accordance with applicable data protection standards, and no information that could directly identify participants will be released.
Data sharing will comply with the research governance and data protection regulations of Assiut University and will be subject to approval by the Faculty of Medicine Research Ethics Committee.
Ramy czasowe udostępniania IPD
Data will be available beginning 6 months after publication and for up to 3 years thereafter.
Kryteria dostępu do udostępniania IPD
Access will be granted to qualified researchers who submit a methodologically sound research proposal and statistical analysis plan.
Requests will be reviewed by the principal investigator and approved by the Faculty of Medicine Research Ethics Committee, Assiut University.
Data will be provided in de-identified form only, and access will require a signed data use agreement specifying permitted uses, data security measures, and prohibition of re-identification.
Data sharing will comply with the research governance and data protection regulations of Assiut University.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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