NCT03246893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

2.5 years

First QC Date

August 3, 2017

Last Update Submit

February 1, 2021

Conditions

Post Extubation Respiratory FailureRe-intubationSeptic ShockSevere Sepsis

Keywords

SepsisSeptic shockSevere sepsisExtubationReintubationNoninvasive positive pressure ventilationHigh flow oxygen nasal cannula

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Reintubation rate

    an average of 1 year

  • 28 day mortality rate

    Upto 28 days

  • Hospital mortality rate

    an average of 1 year

Study Arms (2)

Noninvasive positive pressure ventilation

PLACEBO COMPARATOR

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

Device: Noninvasive positive pressure ventilation

High flow oxygen nasal cannula

EXPERIMENTAL

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

Device: High flow oxygen nasal cannula

Interventions

Noninvasive positive pressure ventilationDEVICE

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

Also known as: NIV
Noninvasive positive pressure ventilation
High flow oxygen nasal cannulaDEVICE

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%

Also known as: HFNC
High flow oxygen nasal cannula

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bangkok, 10700, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 26903338BACKGROUND

  • 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.

    PMID: 34523035DERIVED

MeSH Terms

Conditions

Shock, SepticSepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Surat Tongyoo, Dr

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 11, 2017

Study Start

May 1, 2017

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

February 2, 2021

Record last verified: 2021-02

Locations

TH(1)