Extubation Failure Prevention in High Risk Patients by High-flow Conditioned Oxygen Therapy vs. Standard Oxygen Therapy

Study Overview
=================
Brief Summary
-----------------
Failure of extubation after mechanical ventilation is a frequent and deleterious issue. Main reasons for failure are hypoxemia, secretions retention, lung collapse and excessive work of breathing. Most of this issues can be partly counterbalanced by a device named High flow conditioned oxygen therapy (HFCO). Then, our hypothesis is that HFCO may reduce the incidence of respiratory failure after extubation in patients with high risk for failure.

Official Title
-----------------
Prevention of Post-extubation Respiratory Failure in High Risk Patients by High-flow Conditioned Oxygen Therapy Versus Standard Oxygen Therapy

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Device: Optiflow (Fisher&Paykel)
* Device: Nasal cannulae or controlled oxygen concentration mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients mechanically ventilated for > 48 hours and at least one of the following: >65 years cardiac failure as the primary indication of mechanical ventilation Chronic Obstructive Pulmonary Disease Severity score (APACHE II >12 points) the extubation day Body Mass Index >30 inability to manage respiratory secretions 1 failed spontaneous breathing trial 1 comorbidity 7 days under mechanical ventilation Exclusion Criteria: <18 years tracheotomized patients recent facial or cervical trauma/surgery active gastro-intestinal bleeding lack of cooperation patients with any failed spontaneous breathing trial because of hypercapnia development.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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<br>Intervention: The Optiflow(R) device supplies oxygen in controlled concentrations and at high flow (from 10 to 70 liters/min) through special nasal cannulae. The device also humidifies the gases mixtures up to 100% relative humidity. | Device: Optiflow (Fisher&Paykel)<br>* The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.<br>* Other names: High Flow Conditioned Oxygen Therapy;|
| Active Comparator: Standard Oxygen Therapy<br>The standard way of oxygen supply after extubation is either by nasal cannulae at flow between 1 and 5 liters/min or by mask with controlled oxygen concentration from 24% to 50%. | Device: Nasal cannulae or controlled oxygen concentration mask<br>* The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.<br>* Other names: Standard Oxygen Therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory failure after extubation | Severe hypoxemia (PaO2/Fraction of inspired O2 < 200), hypercapnia (PaCO2 > 50), respiratory acidosis (arterial pH < 7.30), severe tachypnea (>40x') | 72 hours | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post-extubation respiratory failure, Endotracheal intubation, Mechanical ventilation