Efficacy of HFNC Versus NIV for Prevent Reintubation in Sepsis Patients

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

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.

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Noninvasive positive pressure ventilation; After extubation, patient will receive non invasive positive pressure ventilation (NIV) for prevent respiratory and reintubation	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; Other Names: NIV
Experimental: High flow oxygen nasal cannula; After extubation, patient will receive high flow oxygen cannula for prevent respiratory and reintubation	Device: 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%; Other Names: HFNC

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Surat Tongyoo, Dr, Siriraj Hospital

Publications and helpful links

General Publications

• 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.
• Tongyoo S, Tantibundit P, Daorattanachai K, Viarasilpa T, Permpikul C, Udompanturak S. High-flow nasal oxygen cannula vs. noninvasive mechanical ventilation to prevent reintubation in sepsis: a randomized controlled trial. Ann Intensive Care. 2021 Sep 14;11(1):135. doi: 10.1186/s13613-021-00922-5.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Septic shock; Sepsis; Noninvasive positive pressure ventilation; Extubation; High flow oxygen nasal cannula; Severe sepsis; Reintubation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Respiration Disorders; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Toxemia; Shock, Septic; Respiratory Insufficiency
• Other Study ID Numbers: Si212/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No