Efficacy of HFNC Versus NIV for Prevent Reintubation in Sepsis Patients

NCT ID: NCT03246893

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-10-31

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.

Conditions

Post Extubation Respiratory Failure; Re-intubation; Septic Shock; Severe Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Noninvasive positive pressure ventilation

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

Group Type: PLACEBO_COMPARATOR

Noninvasive positive pressure ventilation

Intervention Type: 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

High flow oxygen nasal cannula

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

Group Type: EXPERIMENTAL

High flow oxygen nasal cannula

Intervention Type: 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%

Interventions

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

Intervention Type: 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%

Intervention Type: DEVICE

Other Intervention Names

NIV; HFNC

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Surat Tongyoo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Surat Tongyoo, Dr

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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

Bangkok, , Thailand

Countries

Thailand

References

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.

Reference Type: BACKGROUND

PMID: 26903338 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34523035 (View on PubMed)

Other Identifiers

Si212/2017

Identifier Type: -

Identifier Source: org_study_id