High-flow Conditioned Oxygen Therapy Versus Non-invasive Ventilation: Prevention of Post-extubation Failure

Study Overview
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Brief Summary
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The main aim is to demonstrate whether the high flow conditioned oxygen therapy reduces the reintubation rate. Post-extubation respiratory failure risk will be stratified (as the randomization). In high risk patients high flow conditioned oxygen therapy will be compared with with not conditioned non-invasive mechanical ventilation. In low risk patients comparison will be conventional oxygen therapy. Hypercapnic patients will be excluded.

Official Title
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Comparison Between High-flow Conditioned Oxygen Therapy and Non-invasive Ventilation in Prevention of Post-extubation Respiratory Failure. A Randomized Controlled Trial

Conditions
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Post-extubation Respiratory Failure

Intervention / Treatment
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* Device: High Flow Conditioned Oxygen Therapy in High Risk Patients
* Device: Non-invasive mechanical ventilation
* Device: Conventional Oxygen Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low Risk Patients: Any extubated patients after tolerating a spontaneous breathing trial. High Risk Patients: Any extubated patients after >48 hours under mechanical ventilation and any of the following: >65 years cardiac failure as the primary indication of mechanical ventilation COPD APACHE II >12 points the extubation day BMI >30 inability to manage respiratory secretions 1 failed spontaneous breathing trial 1 comorbidity 7 days under mechanical ventilation Exclusion Criteria: <18 years thacheotomized patients recent facial or cervical trauma/surgery active gastro-intestinal bleeding lack of cooperation and patients with any failed spontaneous breathing trial because of hypercapnia development.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Flow Conditioned Oxygen Therapy in high risk patients<br> | Device: High Flow Conditioned Oxygen Therapy in High Risk Patients<br>* OptiFlow system (R) with nasal cannula.<br>|
| Active Comparator: Non-invasive mechanical ventilation in High Risk Patients<br> | Device: Non-invasive mechanical ventilation<br>* Bilevel pressure support through a facial mask<br>|
| Experimental: High Flow Conditioned Oxygen Therapy in Low Risk Patients<br> | Device: High Flow Conditioned Oxygen Therapy in High Risk Patients<br>* OptiFlow system (R) with nasal cannula.<br>|
| Active Comparator: Conventional Oxygen Therapy in Low Risk Patients<br> | Device: Conventional Oxygen Therapy<br>* Conventional Oxygen Therapy with nasal cannula or Venturi facial mask.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-extubation respiratory failure and Reintubation rate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Care Unit mortality rate |  | 3 month | 
| Hospital mortality rate |  | 6 months | 
| Intensive Care Unit length of stay |  | 3 months | 
| Hospital length of stay |  | 6 months | 
| Nosocomial pneumonia rate |  | 3 months | 
| Tracheobronchitis rate |  | 3 months |