Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure

Study Overview
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Brief Summary
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The purpose of this study is to determine whether helmet is effective as device for noninvasive positive pressure ventilation in the weaning from mechanical ventilation.

Detailed Description
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The clinical efficacy of noninvasive positive pressure ventilation (NPPV) has been demonstrated. Interest has emerged in using NPPV to facilitate earlier removal of an endotracheal tube and decrease complications associated with prolonged intubation. Studies assessing NPPV in weaning are not enough and generally are performed with face masks as device for NPPV. This study assesses the efficacy of helmet as device for NPPV during weaning from mechanical ventilation in an ICU and compares this procedure with invasive mechanical complication (IMV) by analyzing respiratory parameters, clinical course and complications.

Official Title
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Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure

Conditions
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Inadequate or Impaired Breathing Pattern or Ventilation

Intervention / Treatment
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* Device: Helmet
* Device: Endotracheal tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: endotracheal mechanical ventilation for 48 hours or more for acute respiratory failure, patient ready to be weaned (steady respiratory and hemodynamic conditions for 24 hours), spontaneous breathing trial failure written informed consent obtained (patient or family) Exclusion Criteria: respiratory and hemodynamic instability initial difficult intubation bronchial hypersecretion at the weaning time non cooperant patient recent history of upper gastro-intestinal surgery recent history of myocardial infarction

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 |
| --- | --- |
| Active Comparator: Helmet NPPV<br>Weaning from mechanical ventilation with noninvasive positive pressure ventilation (NPPV)delivered by means of the helmet | Device: Helmet<br>* Weaning from mechanical ventilation with noninvasive positive pressure ventilation delivered by means of the helmet<br>|
| Sham Comparator: ETT IMV<br>Weaning from mechanical ventilation with standard invasive mechanical ventilation (IMV) delivered by means of the endotracheal tube (ETT) | Device: Endotracheal tube<br>* Weaning from mechanical ventilation with invasive mechanical ventilation delivered by means of the endotracheal tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure | Main end-point defined as the weaning success/failure rate | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure | Intubation duration Total duration of mechanical ventilation (endotracheal and non invasive) Weaning process duration Stress response evaluation Daily duration of ventilatory support ICU lentgh of stay Hospital lentgh of stay | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, Weaning, Noninvasive ventilation, Acute respiratory failure, Helmet