Efficacy of HFNC Versus NIV for Prevent Reintubation in Sepsis Patients

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246893
• Other study ID #: Si212/2017
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: February 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Extubation Respiratory Failure
• Re-intubation
• Respiratory Insufficiency
• Sepsis
• Septic Shock
• Severe Sepsis
• Shock, Septic
• Toxemia

Intervention

Device:
• Noninvasive positive pressure ventilation
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
• High flow oxygen nasal cannula
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%

Locations

Country	Name	City	State
Thailand	Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reintubation rate	Patient develope respiratory failure, requiring reintubation within 72 hours after extubation	an average of 1 year
Secondary	28 day mortality rate	Proportion of dead patients to overall patients	Upto 28 days
Secondary	Hospital mortality rate	Proportion of dead patients to overall patients from extubation to discharge date	an average of 1 year