Noninvasive 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 (NIV) in the prevention of extubation failure and mortality in patients with either chronic respiratory disorders or hypercapnic respiratory failure during spontaneous breathing.

Detailed Description
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Reintubation, which occurs in 6 to 23% within 48 to 72 hours after planned extubation, is a relevant consequence of respiratory failure after extubation. Patients with chronic respiratory disorders and invasively mechanically ventilated in intensive care unit, often exhibit hypercapnia, during breathing trial prior extubation. This is associated to increased incidence of extubation failure and mortality. Although the need for reintubation may be a marker of increased severity of illness, this is an independent risk factor for nosocomial pneumonia, increased hospital stay and mortality. NIV does not seem to be beneficial in avoiding reintubation when these patients have developed respiratory failure. However, a recent randomised study demonstrated that the early use of NIV averted respiratory failure after extubation in patients at increased risk. The patients were considered at risk if they had at least one of the following criteria: age > 65 years, cardiac failure, increased severity assessed by an Acute Physiologic and Chronic Health Evaluation score > 12. But, the beneficial effects of NIV on survival appear to be restricted to patients with chronic respiratory disorders and hypercapnia during the spontaneous breathing trial. So the beneficial effects of NIV should be confirmed in a trial in this specific population. We planned to conduct a study evaluating the efficacy of NIV in the prevention of extubation failure and mortality in these patients. If no signs of respiratory failure appeared after 120 min of a spontaneous breathing trial, patients will be extubated and randomly allocated after extubation to NIV group or control group. The clinical follow-up will be as follow: the incidence of extubation failure, the reintubation, the ICU and hospital mortality, 28-day survival, the complications associated to mechanical ventilation, ICU and hospital length of stay.

Official Title
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Sequential and Early Used of Noninvasive Ventilation After Extubation in Hypercapnic Patients or in Patients With Chronic Respiratory Disorders

Conditions
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Respiratory Failure

Intervention / Treatment
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* Procedure: Noninvasive ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients intubated for 48 hours or more Patients with Chronic respiratory disorders And/or hypercapnic respiratory failure during successful spontaneous breathing trial Exclusion Criteria: Face or cranial trauma or surgery Home noninvasive ventilation Recent gastric or oesophageal surgery Tracheostomy or other upper airway disorders Upper gastrointestinal bleeding Excess respiratory secretions Lack of collaboration Do not resuscitate order or any decision to limit therapeutic effort in the ICU.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIV<br> | Procedure: Noninvasive ventilation<br>* NIV will be delivered using a sequential mode (a minimum of 1 hour every 3 hours) immediately after extubation for a schedule period of 48 h after extubation. In between NIV courses ((NIV-free periods) O2 will be administered through nasal cannula in order to obtain a SaO2 ≥ 90%. Afterward, NIV will be withdraw and oxygen will be administered by nasal cannula<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of respiratory failure after extubation |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of reintubation |  | 2 months | 
| Length of stay in Intensive Care Unit |  | 2 months | 
| Hospital mortality |  | 2 months | 
| Survival |  | 28th day | 
| Survival |  | 90th day | 
| Incidence of complications associated to mechanical ventilation |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic respiratory disorders, hypercapnic respiratory failure, noninvasive ventilation