Regional Diaphragmatic Synchrony Index for Predicting Weaning Outcomes During Pressure Support Ventilation Spontaneous Breathing Trials
23 juillet 2026 mis à jour par: Huiqing Ge, Sir Run Run Shaw Hospital
Regional Diaphragmatic Synchrony Index for Predicting Weaning Outcomes During Pressure Support Ventilation Spontaneous Breathing Trials: A Prospective Observational Study
The primary aim of this study is to evaluate the predictive value of the inspiratory regional diaphragmatic synchrony index (RDSI-insp) during PSV-SBT for first-attempt weaning failure.
Secondary objectives include: (1) assessing the correlation between RDSI-insp and conventional respiratory mechanics and diaphragmatic ultrasound parameters such as RSBI, MIP/NIF, VC, CPF, P0.1, DE, and DTF; (2) comparing differences in RDSI and DPSI between successful and failed weaning groups during inspiration, end-inspiration, and expiration; (3) exploring the association of anterior diaphragmatic dyssynchrony index, posterior/crural dyssynchrony index, and regional time-to-peak dispersion with weaning outcomes; and (4) evaluating the feasibility, analyzable image rate, and repeatability of diaphragmatic speckle-tracking and RDSI calculation in patients undergoing PSV-SBT.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Estimé)
110
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Huiqing Ge, MD
- Numéro de téléphone: +8613588706787
- E-mail: gehq@zju.edu.cn
Sauvegarde des contacts de l'étude
- Nom: YIqing Xu, Master
- Numéro de téléphone: +86 13634115344
- E-mail: xuyiqing@srrsh.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
The study population will consist of adult patients (aged 18 years and older) who have received invasive mechanical ventilation for at least 24 hours and are clinically ready for their first Spontaneous Breathing Trial (SBT) under Pressure Support Ventilation (PSV) mode.
Eligible participants must be hemodynamically stable (MAP ≥ 65 mmHg with or without low-dose vasopressors) and have adequate oxygenation (FiO2 ≤ 0.60 and PEEP ≤ 10 cmH2O) to safely undergo the SBT.
Patients with known diaphragm paralysis, inadequate ultrasound windows, severe agitation, or those who are pregnant will be excluded.
Written informed consent will be obtained from the patient or their legally authorized representative prior to enrollment.
La description
Inclusion Criteria:
- Age: Age ≥ 18 years.
- Mechanical Ventilation Duration: Receiving invasive mechanical ventilation for ≥ 24 hours.
- Weaning Readiness: The attending physician has determined that the patient meets the criteria for weaning assessment and plans to conduct a Spontaneous Breathing Trial (SBT) under Pressure Support Ventilation (PSV) mode.
- Hemodynamic Stability: Hemodynamically stable prior to the SBT, defined as a mean arterial pressure (MAP) ≥ 65 mmHg, or requiring only low-dose vasopressor support.
- Oxygenation Criteria: Oxygenation status permits an SBT, typically defined as FiO2 ≤ 0.60 and PEEP ≤ 10 cmH2O, or meeting the standard weaning assessment criteria of the participating institution.
Exclusion Criteria:
- Known or highly suspected phrenic nerve injury, or unilateral/bilateral diaphragmatic paralysis.
- Neuromuscular diseases causing severely restricted spontaneous breathing capacity, as judged by the investigator to be unsuitable for RDSI analysis.
- Recent chest or upper abdominal surgery, open trauma, skin infection, or extensive dressing coverage that prevents obtaining a reliable diaphragm ultrasound window.
- Significant agitation or severe patient-ventilator asynchrony that prevents the acquisition of continuous and stable respiratory cycles.
- Undrained pneumothorax, or conditions deemed unsuitable for ultrasound examination as judged by the attending physician.
- Pregnant patients.
- The patient or their legally authorized representative refuses to participate in the study.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Weaning Success
Patients who successfully pass the first PSV-SBT and remain free from reintubation or rescue non-invasive ventilation (NIV)/high-flow nasal cannula (HFNC) for at least 48 hours post-extubation due to respiratory failure or failure of airway protection.
|
Patients undergoing their first Spontaneous Breathing Trial (SBT) under Pressure Support Ventilation (PSV) will receive diaphragm ultrasound examinations.
The investigators will measure diaphragm excursion (DE) and thickening fraction (DTF) to calculate the Respiratory Diaphragm-SB Index (RDSI).
Conventional weaning parameters (RSBI, MIP, P0.1, etc.) will also be recorded simultaneously.
The results will be compared to predict weaning outcomes (successful extubation vs. failure/reintubation).
|
|
Weaning Failure
Patients who fail the first PSV-SBT, or those who pass the SBT but require reintubation or rescue NIV/HFNC within 48 hours post-extubation due to respiratory failure or failure of airway protection.
|
Patients undergoing their first Spontaneous Breathing Trial (SBT) under Pressure Support Ventilation (PSV) will receive diaphragm ultrasound examinations.
The investigators will measure diaphragm excursion (DE) and thickening fraction (DTF) to calculate the Respiratory Diaphragm-SB Index (RDSI).
Conventional weaning parameters (RSBI, MIP, P0.1, etc.) will also be recorded simultaneously.
The results will be compared to predict weaning outcomes (successful extubation vs. failure/reintubation).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of first-attempt weaning failure
Délai: Up to 48 hours post-extubation (or duration of the first PSV-SBT if failed)
|
First-attempt weaning failure, defined as failure of the first PSV-SBT, or extubation following a successful SBT but requiring reintubation within 48 hours due to respiratory failure or failure of airway protection.
|
Up to 48 hours post-extubation (or duration of the first PSV-SBT if failed)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rescue NIV/HFNC within 48 or 72 hours post-extubation
Délai: - Up to 72 hours post-extubation
|
- Proportion of patients requiring reintubation for any reason (e.g., respiratory failure, decreased airway protection) within 72 hours after extubation.
|
- Up to 72 hours post-extubation
|
|
- Rescue NIV/HFNC within 48 or 72 hours post-extubation
Délai: - Up to 48 hours or 72 hours post-extubation
|
- Proportion of patients requiring urgent initiation of non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) due to respiratory distress or hypoxemia within 48 or 72 hours after extubation.
|
- Up to 48 hours or 72 hours post-extubation
|
|
- Ventilator-free days at 28 days (D28)
Délai: - Up to 28 days post-enrollment
|
- The number of days from the first successful weaning and extubation until day 28, during which the patient is alive and free from invasive mechanical ventilation.
If the patient dies or remains on mechanical ventilation for more than 28 days, it is recorded as 0 days.
|
- Up to 28 days post-enrollment
|
|
- Length of stay in the ICU and hospital
Délai: From the date of randomization until the date of ICU discharge or hospital discharge, whichever came first, assessed up to 12 months.
|
- The number of days from enrollment (day of first SBT) to ICU discharge, and from enrollment to final hospital discharge.
|
From the date of randomization until the date of ICU discharge or hospital discharge, whichever came first, assessed up to 12 months.
|
|
- ICU mortality and in-hospital mortality
Délai: From the date of randomization until the date of ICU discharge or death, whichever came first, assessed up to 12 months.
|
- The proportion of patients who die during their ICU stay and during the entire hospital stay (until discharge).
|
From the date of randomization until the date of ICU discharge or death, whichever came first, assessed up to 12 months.
|
|
- Correlation between RDSI and conventional respiratory mechanics/diaphragm ultrasound parameters
Délai: At the end of the first PSV-SBT (approximately 30 to 120 minutes post-initiation)
|
- Assessment of the statistical correlation between the novel RDSI index and conventional weaning predictors, including Rapid Shallow Breathing Index (RSBI), Maximum Inspiratory Pressure (MIP/NIF), Vital Capacity (VC), Cough Peak Flow (CPF), Airway Occlusion Pressure (P0.1),
Diaphragmatic Excursion (DE), and Diaphragm Thickening Fraction (DTF).
|
At the end of the first PSV-SBT (approximately 30 to 120 minutes post-initiation)
|
|
- Feasibility and reliability of RDSI image acquisition and speckle tracking
Délai: At the end of the first PSV-SBT, up to 120 minutes post-initiation (upon image completion)
|
- Assessment of the acquisition rate of diaphragm ultrasound images, the analyzability rate (proportion of successful speckle tracking analysis), and the inter-observer and intra-observer measurement agreement (Intraclass Correlation Coefficient, ICC).
|
At the end of the first PSV-SBT, up to 120 minutes post-initiation (upon image completion)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Umbrello M, Formenti P, Longhi D, Galimberti A, Piva I, Pezzi A, Mistraletti G, Marini JJ, Iapichino G. Diaphragm ultrasound as indicator of respiratory effort in critically ill patients undergoing assisted mechanical ventilation: a pilot clinical study. Crit Care. 2015 Apr 13;19(1):161. doi: 10.1186/s13054-015-0894-9.
- Mahmoodpoor A, Fouladi S, Ramouz A, Shadvar K, Ostadi Z, Soleimanpour H. Diaphragm ultrasound to predict weaning outcome: systematic review and meta-analysis. Anaesthesiol Intensive Ther. 2022;54(2):164-174. doi: 10.5114/ait.2022.117273.
- Parada-Gereda HM, Tibaduiza AL, Rico-Mendoza A, Molano-Franco D, Nieto VH, Arias-Ortiz WA, Perez-Teran P, Masclans JR. Effectiveness of diaphragmatic ultrasound as a predictor of successful weaning from mechanical ventilation: a systematic review and meta-analysis. Crit Care. 2023 May 5;27(1):174. doi: 10.1186/s13054-023-04430-9.
- Park JE, Kim DY, Park JW, Jung YJ, Lee KS, Park JH, Sheen SS, Park KJ, Sunwoo MH, Chung WY. Development of a Machine Learning Model for Predicting Weaning Outcomes Based Solely on Continuous Ventilator Parameters during Spontaneous Breathing Trials. Bioengineering (Basel). 2023 Oct 5;10(10):1163. doi: 10.3390/bioengineering10101163.
- Thille AW, Gacouin A, Coudroy R, Ehrmann S, Quenot JP, Nay MA, Guitton C, Contou D, Labro G, Reignier J, Pradel G, Beduneau G, Dangers L, Saccheri C, Prat G, Lacave G, Sedillot N, Terzi N, La Combe B, Mira JP, Romen A, Azais MA, Rouze A, Devaquet J, Delbove A, Dres M, Bourenne J, Lautrette A, de Keizer J, Ragot S, Frat JP; REVA Research Network. Spontaneous-Breathing Trials with Pressure-Support Ventilation or a T-Piece. N Engl J Med. 2022 Nov 17;387(20):1843-1854. doi: 10.1056/NEJMoa2209041. Epub 2022 Oct 26.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
23 août 2026
Achèvement primaire (Estimé)
21 août 2027
Achèvement de l'étude (Estimé)
30 août 2027
Dates d'inscription aux études
Première soumission
5 juillet 2026
Première soumission répondant aux critères de contrôle qualité
23 juillet 2026
Première publication (Réel)
29 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 20260625
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
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Non
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Non
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