Effect of High-flow Nasal Oxygen on Extubation Outcome

Study Overview
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Brief Summary
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The purpose of this study is to determine whether high flow nasal cannula is effective in lowering the reintubation rate after extubation for high risk patients in medical intensive care unit

Detailed Description
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The study hypothesis is that Optiflow may reduce the extubation failure rate for high risk patients in medical intensive care unit.In the intervention group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive high-flow nasal cannula (Optiflow Airvo2, Fisher & Paykel Healthcare Ltd., New Zealand) after extubation. The oxygen concentration (FiO2) will be set to reach an oxygenation target similar to control patients (see below), while the gas flow rate will be set at 50 L/min.In the control group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive standard oxygen therapy including nasal cannula or oxygen mask after extubation. The FiO2 will be set to obtain a arterial oxygen saturation (SpO2) between 92% and 98% (or between 88% and 95% in hypercapnic patients). NIPPV or intubation will be applied in both group if respiratory distress noted. High flow nasal cannula will be tried before NIPPV or intubation in the control group patients.

Official Title
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Effect of High-flow Nasal Oxygen vs Standard Oxygen Therapy on Extubation Outcome With High Risk of Extubation Failure in Medical ICU Patients

Conditions
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Respiratory Failure, Congestive Heart Failure, COPD

Intervention / Treatment
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* Device: high flow nasal cannula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients mechanically ventilated for > 48 hours and at least one of the following: > 65 y/o Cardiac failure as the primary indication of mechanical ventilation COPD Bronchiectasis Old pulmonary tuberculosis with destructive lung Chronic renal failure Neuromuscular disease BMI > 30 Inability to manage respiratory secretions ARDS Exclusion Criteria: Presence of tracheostomy Recent facial trauma Active gastro-intestinal bleeding Planned NIPPV support after extubation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 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 nasal cannula<br>High flow nasal cannula immediately use after extubation | Device: high flow nasal cannula<br>* High flow nasal cannula used in postextubation patients<br>* Other names: Optiflow Airvo2 (Fisher & Paykel Healthcare);|
| Placebo Comparator: stanrd oxygen therapy<br>Oxygen cannula or mask after extubation | Device: high flow nasal cannula<br>* High flow nasal cannula used in postextubation patients<br>* Other names: Optiflow Airvo2 (Fisher & Paykel Healthcare);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reintubation rate |  | 72 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Non-Invasive Ventilation |  | at day 28 after inclusion in the study | 
| ICU readmission rate due to respiratory failure |  | at day 28 after inclusion in the study | 
| ICU mortality rate |  | at day 28 after inclusion in the study | 
| ICU length of stay |  | at day 28 after inclusion in the study | 
| Hospital mortality |  | at day 28 after inclusion in the study | 
| Hospital length of stay |  | at day 28 after inclusion in the study | 
| Nosocomial pneumonia rate |  | at day 28 after inclusion in the study | 
| Desaturation ( SaO2< 90%) |  | 72 hours after extubation | 
| Severe hypoxemia (PaO2/Fraction of inspired O2 < 200) |  | Time Frame: 72 hours after extubation | 
| hypercapnia (PaCO2 > 50) |  | 72 hours after extubation | 
| respiratory acidosis (arterial pH < 7.30) |  | 72 hours after extubation | 
| severe tachypnea (>40/min) |  | 72 hours after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high flow nasal cannula, extubation failure