Efficacy of HFNC Versus NIV for Prevent Reintubation in Sepsis Patients

Study Overview
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Brief Summary
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Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory failure and prevent reintubation in comparable with NIV among post cardiothoracic surgery and high risk for reintubated patients. There was no information about HFNC versus NIV in prevention of reintubation among severe sepsis or septic shock patients.

Detailed Description
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Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory failure and prevent reintubation. The results from recent randomized controlled trials, comparing HFNC with NIV for prevent post extubation respiratory failure among post cardiac surgery and high risk patients, showed no significant different in the treatment outcome.comparable with NIV among post cardiothoracic surgery and high risk for reintubated patients. About 40-85% of severe sepsis/septic shock patients developed acute respiratory failure, required endotracheal intubation. According to the nature of patients population, usually eldery, multiple co-morbid condition and high APACHE II score, sepsis patients were considerred as high risk for reintubation, after extubated. There was no information about HFNC versus NIV in prevention of reintubation among severe sepsis or septic shock patients.

Official Title
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Efficacy of High Flow Oxygen Nasal Cannula Versus Noninvasive Positive Pressure Ventilation After Extubation in Sepsis Patients

Conditions
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Post Extubation Respiratory Failure, Re-intubation, Septic Shock, Severe Sepsis

Intervention / Treatment
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* Device: Noninvasive positive pressure ventilation
* Device: High flow oxygen nasal cannula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of sepsis or septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) Depended on mechanical ventilator for more than 48 hours Plan for extubation due to successful weaning Exclusion Criteria: Patient with tracheostomy Recent upper abdominal surgery Wound at face that prohibit face-mask application Patient or 1st degree relative not agree to participate trial Physician prefer either NIV or HFNC for the patient

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Noninvasive positive pressure ventilation<br>After extubation, patient will receive non invasive positive pressure ventilation (NIV) for prevent respiratory and reintubation | Device: Noninvasive positive pressure ventilation<br>* Noninvasive positive pressure ventilation will apply via a face mask with initial setting as the following: Inspiratory pressure 6-8 cmH2O Expiratory pressure 3-5 cmH2O FiO2 30-60% Respiratory rate 12-16 per min<br>* Other names: NIV;|
| Experimental: High flow oxygen nasal cannula<br>After extubation, patient will receive high flow oxygen cannula for prevent respiratory and reintubation | Device: High flow oxygen nasal cannula<br>* High flow oxygen nasal cannula will apply to patient via a nasal cannula with initial setting as the following: Temperature 37 degree celsius Flow 30 liter per min FiO2 40-60%<br>* Other names: HFNC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device failure rate | Device failure to prevent reintubation, patient discomfort, change to another device within 72 hours after extubation | an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintubation rate | Patient develope respiratory failure, requiring reintubation within 72 hours after extubation | an average of 1 year | 
| 28 day mortality rate | Proportion of dead patients to overall patients | Upto 28 days | 
| Hospital mortality rate | Proportion of dead patients to overall patients from extubation to discharge date | an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Septic shock, Severe sepsis, Extubation, Reintubation, Noninvasive positive pressure ventilation, High flow oxygen nasal cannula