Efficacy of HFNC Versus NIV for Prevent Reintubation in Sepsis Patients

Not Applicable

Completed

• Conditions: Post Extubation Respiratory Failure; Re-intubation; Septic Shock; Severe Sepsis
• Interventions: Device: High flow oxygen nasal cannula; Device: Noninvasive positive pressure ventilation

• Registration Number: NCT03246893
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-11
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High flow oxygen nasal cannula	High flow oxygen nasal cannula	After extubation, patient will receive high flow oxygen cannula for prevent respiratory and reintubation
Noninvasive positive pressure ventilation	Noninvasive positive pressure ventilation	After extubation, patient will receive non invasive positive pressure ventilation (NIV) for prevent respiratory and reintubation

Primary Outcome Measures

Name	Time	Method
Device failure rate	an average of 1 year	Device failure to prevent reintubation, patient discomfort, change to another device within 72 hours after extubation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand