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Efficacy of HFNC Versus NIV for Prevent Reintubation in Sepsis Patients

Primary Purpose

Post Extubation Respiratory Failure, Re-intubation, Septic Shock

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Noninvasive positive pressure ventilation
High flow oxygen nasal cannula
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Extubation Respiratory Failure focused on measuring Sepsis, Septic shock, Severe sepsis, Extubation, Reintubation, Noninvasive positive pressure ventilation, High flow oxygen nasal cannula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Noninvasive positive pressure ventilation

High flow oxygen nasal cannula

Arm Description

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

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

Outcomes

Primary Outcome Measures

Device failure rate
Device failure to prevent reintubation, patient discomfort, change to another device within 72 hours after extubation

Secondary Outcome Measures

Reintubation rate
Patient develope respiratory failure, requiring reintubation within 72 hours after extubation
28 day mortality rate
Proportion of dead patients to overall patients
Hospital mortality rate
Proportion of dead patients to overall patients from extubation to discharge date

Full Information

First Posted
August 3, 2017
Last Updated
February 1, 2021
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT03246893
Brief Title
Efficacy of HFNC Versus NIV for Prevent Reintubation in Sepsis Patients
Official Title
Efficacy of High Flow Oxygen Nasal Cannula Versus Noninvasive Positive Pressure Ventilation After Extubation in Sepsis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Extubation Respiratory Failure, Re-intubation, Septic Shock, Severe Sepsis
Keywords
Sepsis, Septic shock, Severe sepsis, Extubation, Reintubation, Noninvasive positive pressure ventilation, High flow oxygen nasal cannula

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Noninvasive positive pressure ventilation
Arm Type
Placebo Comparator
Arm Description
After extubation, patient will receive non invasive positive pressure ventilation (NIV) for prevent respiratory and reintubation
Arm Title
High flow oxygen nasal cannula
Arm Type
Experimental
Arm Description
After extubation, patient will receive high flow oxygen cannula for prevent respiratory and reintubation
Intervention Type
Device
Intervention Name(s)
Noninvasive positive pressure ventilation
Other Intervention Name(s)
NIV
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
High flow oxygen nasal cannula
Other Intervention Name(s)
HFNC
Intervention Description
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%
Primary Outcome Measure Information:
Title
Device failure rate
Description
Device failure to prevent reintubation, patient discomfort, change to another device within 72 hours after extubation
Time Frame
an average of 1 year
Secondary Outcome Measure Information:
Title
Reintubation rate
Description
Patient develope respiratory failure, requiring reintubation within 72 hours after extubation
Time Frame
an average of 1 year
Title
28 day mortality rate
Description
Proportion of dead patients to overall patients
Time Frame
Upto 28 days
Title
Hospital mortality rate
Description
Proportion of dead patients to overall patients from extubation to discharge date
Time Frame
an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surat Tongyoo, Dr
Organizational Affiliation
Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26903338
Citation
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.
Results Reference
background
PubMed Identifier
34523035
Citation
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.
Results Reference
derived

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Efficacy of HFNC Versus NIV for Prevent Reintubation in Sepsis Patients

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