Efficacy of HFNC Versus NIV for Prevent Reintubation in Sepsis Patients

Mahidol University

Status: Completed

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

Treatments: Device: High flow oxygen nasal cannula; Device: Noninvasive positive pressure ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03246893

Si212/2017

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups, including a placebo group

Noninvasive positive pressure ventilation

Placebo Comparator group

Description:

After extubation, patient will receive non invasive positive pressure ventilation (NIV) for prevent respiratory and reintubation

Treatment:

Device: Noninvasive positive pressure ventilation

High flow oxygen nasal cannula

Experimental group

Description:

After extubation, patient will receive high flow oxygen cannula for prevent respiratory and reintubation

Treatment:

Device: High flow oxygen nasal cannula