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OpenTrials
Completed

NCT Number: NCT03246893

Efficacy of HFNC Versus NIV for Prevent Reintubation 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noninvasive Positive Pressure Ventilation

Device

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

High flow oxygen nasal cannula

Device

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

Primary outcomes

  1. Device failure rate

    Time frame: an average of 1 year

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

Secondary outcomes

  1. Reintubation rate

    Time frame: an average of 1 year

    Patient develope respiratory failure, requiring reintubation within 72 hours after extubation

  2. 28 day mortality rate

    Time frame: Upto 28 days

    Proportion of dead patients to overall patients

  3. Hospital mortality rate

    Time frame: an average of 1 year

    Proportion of dead patients to overall patients from extubation to discharge date

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2017
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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