Post Extubation Respiratory FailureNCT03246893
Efficacy of HFNC Versus NIV for Prevent Reintubation in Sepsis Patients
A study testing Noninvasive positive pressure ventilation and High flow oxygen nasal cannula in people with Post Extubation Respiratory Failure and Re-intubation, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Extubation Respiratory Failure, Re-intubation, Septic Shock
- What is being tested?
- Noninvasive positive pressure ventilation and High flow oxygen nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2017to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: 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.
Read the 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.
- Being tested
- Noninvasive positive pressure ventilation, High flow oxygen nasal cannula
- Keywords
- Sepsis, Septic shock, Severe sepsis, Extubation, Reintubation, Noninvasive positive pressure ventilation, High flow oxygen nasal cannula
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive positive pressure ventilationDevice
Also called NIV
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 cannulaDevice
Also called HFNC
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%
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive positive pressure ventilation | Placebo comparator | After extubation, patient will receive non invasive positive pressure ventilation (NIV) for prevent respiratory and reintubation Receives: 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 Receives: Device: High flow oxygen nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device failure rate
Device failure to prevent reintubation, patient discomfort, change to another device within 72 hours after extubation
Measured: an average of 1 year
Secondary outcomes (3)
Reintubation rate
Patient develope respiratory failure, requiring reintubation within 72 hours after extubation
Measured: an average of 1 year
28 day mortality rate
Proportion of dead patients to overall patients
Measured: Upto 28 days
Hospital mortality rate
Proportion of dead patients to overall patients from extubation to discharge date
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start1 May 2017
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Extubation Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surat Tongyoo, Mahidol University
- Investigators
- Surat Tongyoo, Dr, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246893
- Sponsor's protocol ID
- Si212/2017
- Status last verified
- Feb 2021
- First submitted
- 3 Aug 2017
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26903338Tongyoo 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.
PubMed 34523035
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Flow Oxygen Nasal Cannula Versus Noninvasive Positive Pressure Ventilation After Extubation in Sepsis Patients
- ClinicalTrials.gov ID
- NCT03246893
- Acronym / sponsor ID
- Si212/2017
- Keywords
- Sepsis, Septic shock, Severe sepsis, Extubation, Reintubation, Noninvasive positive pressure ventilation, High flow oxygen nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive positive pressure ventilation | Placebo comparator | Device: Noninvasive positive pressure ventilationAfter extubation, patient will receive non invasive positive pressure ventilation (NIV) for prevent respiratory and reintubation |
| High flow oxygen nasal cannula | Experimental | Device: High flow oxygen nasal cannulaAfter extubation, patient will receive high flow oxygen cannula for prevent respiratory and reintubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive positive pressure ventilationAlso: NIVNoninvasive 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 | Device | Noninvasive positive pressure ventilation |
| High flow oxygen nasal cannulaAlso: HFNCHigh 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% | Device | High flow oxygen nasal cannula |
Primary outcome
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
3 secondary outcomes
Reintubation rate
Time frame: an average of 1 year
28 day mortality rate
Time frame: Upto 28 days
Hospital mortality rate
Time frame: an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Background: PubMed 26903338Singer 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.
- Derived from this study: PubMed 34523035Tongyoo 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.
- Individual participant dataSharing planned: Undecided
Related trials for Post Extubation Respiratory Failure
Not yet recruitingObservational study
Combined RSBI, TOF, and BIS for Prediction of Extubation Success
Extubation Success, Extubation Failure
Not yet recruiting
Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation After Extubation in Neonates
Extubation Failure in Neonates
Recruiting
A Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure
Systolic Heart Failure, Respiratory Failure
Recruiting
Non-Invasive Ventilation Versus High-flow Nasal Oxygen in Intensive Care Units
Post Extubation Respiratory Failure
Active, not recruiting
High-Flow Nasal Cannula Versus Noninvasive Ventilation After Extubation in Patients With COPD and Mild Hypercapnic Respiratory Failure
COPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surat Tongyoo, Dr principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive positive pressure ventilation and High flow oxygen nasal cannula in people with Post Extubation Respiratory Failure and Re-intubation, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device failure rate (time frame: an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03246893, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.