Non-Invasive Ventilation After Extubation in Hypercapnic Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of noninvasive ventilation in the prevention of extubation failure and mortality in patients with chronic respiratory disorders and hypercapnic respiratory failure during spontaneous breathing.

Detailed Description
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Background and aims: Patients with chronic respiratory disorders, intubated and mechanically-ventilated in intensive care units (ICU), often exhibit hypercapnia during the spontaneous breathing trial prior to extubation; this is associated to increased incidence of extubation failure and mortality. We will assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in these patients. Design: Prospective, randomized, controlled clinical trial with two groups: support with noninvasive ventilation, and conventional clinical management (control group). Subjects: Patients with chronic respiratory disorders, intubated and ventilated ³48 hours, with hypercapnia (PaCO2 >45 mmHg) during the spontaneous breathing trial, ready to be extubated. Interventions: Random allocation into two groups: NIV immediately after extubation during 24 hours, on conventional clinical management. Clinical follow-up (incidence of extubation failure, reintubation, ICU and hospital mortality, 90-day survival, complications associated to mechanical ventilation, ICU and hospital length of stay). Analyses of data: Comparison between two groups (NIV and control) in non-paired data design: quantitative variables (t-test, Mann-Whitney test, ROC curves), qualitative or categorical variables (chi square, Fisher's exact test), and Kaplan-Meier estimate of survival curves).

Official Title
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Non-Invasive Ventilation After Extubation in Hypercapnic Patients

Conditions
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Respiratory Failure

Intervention / Treatment
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* Procedure: Non-invasive ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic respiratory disorders with invasive mechanical ventilation Hypercapnic respiratory failure during successful spontaneous breathing trial Exclusion Criteria: Face or cranial trauma or surgery Recent gastric or esophageal surgery Tracheostomy or other upper airway disorders Upper gastrointestinal bleeding Excess respiratory secretions Lack of collaboration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIV<br>Non-invasive ventilation | Procedure: Non-invasive ventilation<br>* Non-invasive ventilation after extubation for 24 hours<br>|
| Active Comparator: Control<br>Oxygen therapy | Procedure: Non-invasive ventilation<br>* Non-invasive ventilation after extubation for 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome: The incidence of respiratory failure after extubation |  | 3 days after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive ventilation, Hypercapnic respiratory failure, Mechanical ventilation, Respiratory failure after extubation