Assessment Of Different Indices in Prediction of Noninvasive Ventilation Failure in Patients With Acute Respiratory Failure

May 8, 2023 updated by: Asmaa Abd El Razek Kamel, Assiut University

This study will use different indices for prediction of NIV failure in ARF patients Evaluation of HACOR score and ROX index for early prediction of NIV failure in patients with ARF.

Study value of diaphragmatic dysfunction assessed by ultrasound as tool for prediction of success of NIV in ARF patients.

Compare clinical significance of these scoring systems between hypoxemic and hypercapnic RF

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Noninvasive ventilation (NIV) is a useful and safe method to improve gas exchange in patients with acute respiratory failure (ARF) of different etiologies. NIV reduces the work of breathing, improves arterial oxygenation and alveolar ventilation. It is associated with improved survival in the acute care setting (Cabrini L 2015) when compared to conventional oxygen therapy. As NIV offers several major advantages over invasive ventilation (e.g., preserving the ability to swallow, cough, and communicate verbally), it is widely used to avoid intubation.

Although NIV nowadays is frequently used, its failure rate remains high (25-59%), indicating that not all patients benefit from this treatment. There is an association between the unsuccessful NIV and the poor outcome has been suggested. Among patients who experience NIV failure, either premature or delayed NIV discontinuation further increases mortality. Thus, identifying the predictors of NIV failure is crucial because of the strong link between failure and poor outcomes. So, researchers woke to make scoring systems that may predict NIV failure, as HACOR and ROX indices.

Recently, ultrasonography (US) of the diaphragm as a bedside method is used for evaluation of diaphragmatic function and predicting failure of NIV in acutely ill patients.

Up till now there is limited research to support significance of different indices for prediction of NIV failure and need for invasive mechanical ventilation (IMV).

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients of both gender with acute respiratory failure either hypoxic or hypercapnic who need Noninvasive ventilation.

Description

Inclusion Criteria:

  1. Patients with acute hypoxic respiratory failure who need Noninvasive ventilation.
  2. Patients with acute hypercapnic respiratory failure who need Noninvasive ventilation.

Exclusion Criteria:

  1. Age < 18 years old.
  2. Patients with unconsciousness, severe hemodynamic instability, unable to fit mask (Recent facial surgery, trauma, or deformity), inability to protect the airway or clear respiratory secretions or any other contraindication of NIV.
  3. neuromuscular disease or chest wall deformities.
  4. Pregnancy.
  5. NIV intolerance.
  6. severe obesity with Body Mass Index (BMI)≥35 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure value of HACOR score for prediction of failure of NIV in ARF patients.
Time Frame: Baseline (before starting NIV treatment)
HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as ≤ or > 5
Baseline (before starting NIV treatment)
measure value of HACOR score for prediction of failure of NIV in ARF patients.
Time Frame: at 1 hour of NIV treatment
HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as ≤ or > 5
at 1 hour of NIV treatment
measure value of HACOR score for prediction of failure of NIV in ARF patients.
Time Frame: at 6 hours of NIV treatment
HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as ≤ or > 5
at 6 hours of NIV treatment
measure value of HACOR score for prediction of failure of NIV in ARF patients.
Time Frame: at 12 hours of NIV treatment
HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as ≤ or > 5
at 12 hours of NIV treatment
measure value of HACOR score for prediction of failure of NIV in ARF patients.
Time Frame: at 24 hours of NIV treatment
HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as ≤ or > 5
at 24 hours of NIV treatment
measure value of HACOR score for prediction of failure of NIV in ARF patients.
Time Frame: at 48 hours of NIV treatment
HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as ≤ or > 5
at 48 hours of NIV treatment
measure value of ROX index for prediction of failure of NIV in ARF patients.
Time Frame: Baseline (before starting NIV treatment)
ROX index is the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ fraction of inspired oxygen (FIO2) to respiratory rate (RR). It will be analyzed as continuous value and dichotomized as < or ≥ 4.88
Baseline (before starting NIV treatment)
measure value of ROX index for prediction of failure of NIV in ARF patients.
Time Frame: at first hour of NIV treatment
ROX index is the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ fraction of inspired oxygen (FIO2) to respiratory rate (RR). It will be analyzed as continuous value and dichotomized as < or ≥ 4.88
at first hour of NIV treatment
measure value of ROX index for prediction of failure of NIV in ARF patients.
Time Frame: at 6 hours of NIV treatment
ROX index is the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ fraction of inspired oxygen (FIO2) to respiratory rate (RR). It will be analyzed as continuous value and dichotomized as < or ≥ 4.88
at 6 hours of NIV treatment
measure value of ROX index for prediction of failure of NIV in ARF patients.
Time Frame: at 12 hours of NIV treatment
ROX index is the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ fraction of inspired oxygen (FIO2) to respiratory rate (RR). It will be analyzed as continuous value and dichotomized as < or ≥ 4.88
at 12 hours of NIV treatment
measure value of ROX index for prediction of failure of NIV in ARF patients.
Time Frame: at 24 hours of NIV treatment
ROX index is the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ fraction of inspired oxygen (FIO2) to respiratory rate (RR). It will be analyzed as continuous value and dichotomized as < or ≥ 4.88
at 24 hours of NIV treatment
measure value of ROX index for prediction of failure of NIV in ARF patients.
Time Frame: at 48 hours of NIV treatment
ROX index is the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ fraction of inspired oxygen (FIO2) to respiratory rate (RR). It will be analyzed as continuous value and dichotomized as < or ≥ 4.88
at 48 hours of NIV treatment
diaphragmatic thickness assessment by ultrasound
Time Frame: at first 1 day of starting NIV treatment
ultrasonographic measurement of diaphragmatic thickness fraction for prediction of failure of NIV in ARF patients.
at first 1 day of starting NIV treatment
diaphragmatic dysfunction assessment by ultrasound
Time Frame: at first 1 day of starting NIV treatment
ultrasonographic measurement of diaphragmatic excursion for prediction of failure of NIV in ARF patients.
at first 1 day of starting NIV treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIV failure in acute RF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-invasive Ventilation

Clinical Trials on non invasive ventilation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe