Acute Brain InjuryNCT07664085
High-Flow Nasal Cannula After Extubation in Acute Brain Injury
An observational study of Acute Brain Injury and Post-neurosurgical Status, run by Bach Mai Hospital at 1 site in Vietnam.
Trial summary
Patients with acute brain injury after neurosurgery are at increased risk of extubation failure after removal of the endotracheal tube. High-flow nasal cannula (HFNC) may provide better post-extubation respiratory support than conventional oxygen therapy (COT), but evidence in post-neurosurgical patients remains… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Brain Injury, Post-neurosurgical Status, Extubation Failure
- How many people
- 285 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2025to 30 Jan 2026
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult post-neurosurgical patients with acute brain injury who were admitted to the Surgical Intensive Care Unit of Bach Mai Hospital, required invasive mechanical ventilation for at least 24 hours, and underwent planned extubation after meeting clinical readiness criteria. Patients received either high-flow nasal cannula or conventional oxygen therapy after extubation according to routine clinical practice and the attending ICU physician's decision.
Who may be able to join
- Patients aged 16 years or older.
- Admission to the Surgical Intensive Care Unit after neurosurgery for acute brain injury, including traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke, or other acute neurosurgical brain conditions.
- Requirement for invasive mechanical ventilation for at least 24 hours.
- Undergoing planned extubation after clinical assessment by the treating ICU team.
- Successful completion of a spontaneous breathing trial lasting 30 to 120 minutes.
- Adequate airway protection, defined as an Airway Care Score less than 8 points.
- Neurological readiness for extubation, as assessed by Glasgow Coma Scale score and bedside neurological examination.
- Adequate oxygenation before extubation, including PaO2/FiO2 greater than 200 mmHg and PEEP less than 7 cmH2O.
Who cannot join
- Pre-existing tracheostomy.
- Known upper airway obstruction, including airway stenosis or airway tumor.
- Suspected cerebrospinal fluid leak or complex skull base fracture.
- Unplanned self-extubation.
- Requirement for immediate prophylactic reintubation before initiation of post-extubation oxygen therapy.
- Requirement for non-invasive ventilation before initiation of the study exposure.
- Missing key clinical data required for outcome assessment or propensity score matching.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-Flow Nasal Cannula Versus Conventional Oxygen Therapy After Extubation in Mechanically Ventilated Patients With Acute Brain Injury: A Propensity-Score Overlap-Weighted Observational Cohort Study
Patients with acute brain injury after neurosurgery are at increased risk of extubation failure after removal of the endotracheal tube. High-flow nasal cannula (HFNC) may provide better post-extubation respiratory support than conventional oxygen therapy (COT), but evidence in post-neurosurgical patients remains limited.
This prospective observational study evaluated adult post-neurosurgical patients with acute brain injury who underwent planned extubation in the Surgical Intensive Care Unit of Bach Mai Hospital, Vietnam. Patients received either HFNC or COT after extubation according to routine clinical practice and the decision of the attending ICU physicians. The primary outcome was treatment failure, defined as reintubation or escalation of respiratory support within 5 days after extubation. Secondary outcomes included tracheostomy, ventilator-associated pneumonia, ICU length of stay, total duration of mechanical ventilation, and time from extubation to reintubation. Propensity score matching was used to reduce baseline imbalance between groups.
Read the detailed description
Extubation failure is a clinically important complication in patients with acute brain injury after neurosurgery. These patients may have impaired consciousness, weak cough, reduced airway protection, and limited respiratory reserve, which can increase the risk of reintubation and other postoperative pulmonary complications. High-flow nasal cannula provides heated and humidified oxygen at high flow rates and may improve oxygenation, reduce work of breathing, and support airway clearance after extubation.
This study was designed as a prospective observational cohort study conducted in the Surgical Intensive Care Unit of Bach Mai Hospital. Adult patients aged 16 years or older who were admitted after neurosurgery for acute brain injury, required invasive mechanical ventilation for at least 24 hours, successfully completed a spontaneous breathing trial, had adequate airway protection, and underwent planned extubation were consecutively enrolled. The choice of post-extubation oxygen therapy was not assigned by the investigators. Patients received either HFNC or conventional oxygen therapy according to the attending ICU physician's clinical decision and routine ICU practice.
In the HFNC group, HFNC was initiated immediately after planned extubation when selected by the treating physician. The initial flow rate was 60 L/min, and FiO2 was titrated to maintain SpO2 between 95% and 100%. HFNC was planned for at least the first 24 hours after extubation and was subsequently weaned according to clinical tolerance. In the conventional oxygen therapy group, oxygen was delivered through a standard nasal cannula or face mask, with oxygen flow adjusted to maintain the same SpO2 target.
Clinical data, respiratory parameters, neurological status, arterial blood gas results, oxygen therapy settings, escalation of respiratory support, reintubation, tracheostomy, ventilator-associated pneumonia, duration of mechanical ventilation, and ICU length of stay were collected from ICU medical records, bedside monitoring charts, and nursing or respiratory therapy documentation.
The primary outcome was treatment failure, defined as reintubation or escalation of respiratory support within 5 days after extubation. Secondary outcomes included tracheostomy during ICU stay, ventilator-associated pneumonia, ICU length of stay, total duration of mechanical ventilation, and time from extubation to reintubation. Propensity score matching was performed to reduce selection bias between the HFNC and conventional oxygen therapy groups. Matching variables included age, sex, body mass index, diagnosis category, Glasgow Coma Scale score, airway protection status, duration of mechanical ventilation, and baseline gas exchange variables.
- Conditions
- Acute Brain Injury, Post-neurosurgical Status, Extubation Failure, Postoperative Respiratory Complications, Reintubation
- Keywords
- High-flow nasal cannula, HFNC, Conventional oxygen therapy, Mechanical ventilation, Propensity score matching, Airway Care Score, Neurosurgery, Acute brain injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-Flow Nasal Cannula Group | Patients who received high-flow nasal cannula immediately after planned extubation according to routine clinical practice and the attending ICU physician's decision. HFNC was initiated after extubation with an initial flow rate of 60 L/min, and FiO2 was titrated to maintain SpO2 between 95% and 100%. HFNC was planned to continue for at least the first 24 hours after extubation and was then weaned according to clinical tolerance. | |
| Conventional Oxygen Therapy Group | Patients who received conventional oxygen therapy after planned extubation according to routine clinical practice and the attending ICU physician's decision. Oxygen was delivered via a standard nasal cannula or face mask, with oxygen flow adjusted to maintain SpO2 between 95% and 100%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with treatment failure within 5 days after planned extubation
Treatment failure was defined as reintubation or escalation of respiratory support after planned extubation. Escalation of respiratory support included the need for non-invasive ventilation, rescue high-flow nasal cannula therapy in the conventional oxygen therapy group, or other clinically indicated escalation due to respiratory deterioration. Outcome assessment was based on bedside clinical monitoring, arterial blood gas analysis, respiratory status, neurological status, airway protection assessment, and ICU medical record review.
Measured: Within 5 days after planned extubation
Secondary outcomes (4)
Proportion of patients requiring tracheostomy during ICU stay
The proportion of patients who required tracheostomy after planned extubation. Tracheostomy was identified by review of ICU medical records, operative or procedure notes, and hospital documentation.
Measured: From planned extubation through ICU discharge, assessed up to 30 days after planned extubation
Incidence of ventilator-associated pneumonia during ICU stay
Ventilator-associated pneumonia was assessed by review of hospital medical records using predefined clinical, radiographic, and microbiological criteria, including clinical examination, chest radiograph findings, and microbiological culture results.
Measured: From planned extubation through ICU discharge, assessed up to 30 days after planned extubation
Length of stay in the intensive care unit
ICU length of stay was calculated using the recorded dates and times of ICU admission and ICU discharge from ICU charts and hospital medical records.
Measured: From ICU admission through ICU discharge, assessed up to 30 days after ICU admission
Time from planned extubation to reintubation
Time from planned extubation to reintubation was calculated from the recorded date and time of extubation to the recorded date and time of re-insertion of the endotracheal tube. Patients who were not reintubated were censored at 5 days after extubation.
Measured: From planned extubation through reintubation, assessed up to 5 days after planned extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bach Mai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Toan Thang, Bach Mai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664085
- Sponsor's protocol ID
- BM_2024_241
- Status last verified
- May 2026
- First submitted
- 14 Jun 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the main study results may be shared after publication of the primary results. Data sharing will be considered for researchers conducting systematic reviews, meta-analyses, or methodologically sound secondary analyses. Access will require approval by an ethics committee and a signed data sharing agreement with the study custodian or sponsor. Supporting Information: Study Protocol, Statistical Analysis Plan, Analytic Code, Informed Consent Form Time Frame: Beginning after publication of the main study results; end date not yet determined. Access Criteria: Requests may be submitted by qualified researchers for systematic reviews, meta-analyses, or approved secondary analyses. Data access will require ethics committee approval, a scientifically valid proposal, and completion of a data sharing agreement. Shared data will be de-identified. URL: Leave blank if there is no public repository. Email / Contact: haigmhshmu@gmail.com
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Flow Nasal Cannula Versus Conventional Oxygen Therapy After Extubation in Mechanically Ventilated Patients With Acute Brain Injury: A Propensity-Score Overlap-Weighted Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07664085
- Acronym / sponsor ID
- BM_2024_241
- Conditions
- Acute Brain Injury, Post-neurosurgical Status, Extubation Failure, Postoperative Respiratory Complications, Reintubation
- Keywords
- High-flow nasal cannula, HFNC, Conventional oxygen therapy, Mechanical ventilation, Propensity score matching, Airway Care Score, Neurosurgery, Acute brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Bach Mai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 23 Jun 2026 (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.
Patients with acute brain injury after neurosurgery are at increased risk of extubation failure after removal of the endotracheal tube. High-flow nasal cannula (HFNC) may provide better post-extubation respiratory support than conventional oxygen therapy (COT), but evidence in post-neurosurgical patients remains limited.
This prospective observational study evaluated adult post-neurosurgical patients with acute brain injury who underwent planned extubation in the Surgical Intensive Care Unit of Bach Mai Hospital, Vietnam. Patients received either HFNC or COT after extubation according to routine clinical practice and the decision of the attending ICU physicians. The primary outcome was treatment failure, defined as reintubation or escalation of respiratory support within 5 days after extubation. Secondary outcomes included tracheostomy, ventilator-associated pneumonia, ICU length of stay, total duration of mechanical ventilation, and time from extubation to reintubation. Propensity score matching was used to reduce baseline imbalance between groups.
Detailed description
Extubation failure is a clinically important complication in patients with acute brain injury after neurosurgery. These patients may have impaired consciousness, weak cough, reduced airway protection, and limited respiratory reserve, which can increase the risk of reintubation and other postoperative pulmonary complications. High-flow nasal cannula provides heated and humidified oxygen at high flow rates and may improve oxygenation, reduce work of breathing, and support airway clearance after extubation.
This study was designed as a prospective observational cohort study conducted in the Surgical Intensive Care Unit of Bach Mai Hospital. Adult patients aged 16 years or older who were admitted after neurosurgery for acute brain injury, required invasive mechanical ventilation for at least 24 hours, successfully completed a spontaneous breathing trial, had adequate airway protection, and underwent planned extubation were consecutively enrolled. The choice of post-extubation oxygen therapy was not assigned by the investigators. Patients received either HFNC or conventional oxygen therapy according to the attending ICU physician's clinical decision and routine ICU practice.
In the HFNC group, HFNC was initiated immediately after planned extubation when selected by the treating physician. The initial flow rate was 60 L/min, and FiO2 was titrated to maintain SpO2 between 95% and 100%. HFNC was planned for at least the first 24 hours after extubation and was subsequently weaned according to clinical tolerance. In the conventional oxygen therapy group, oxygen was delivered through a standard nasal cannula or face mask, with oxygen flow adjusted to maintain the same SpO2 target.
Clinical data, respiratory parameters, neurological status, arterial blood gas results, oxygen therapy settings, escalation of respiratory support, reintubation, tracheostomy, ventilator-associated pneumonia, duration of mechanical ventilation, and ICU length of stay were collected from ICU medical records, bedside monitoring charts, and nursing or respiratory therapy documentation.
The primary outcome was treatment failure, defined as reintubation or escalation of respiratory support within 5 days after extubation. Secondary outcomes included tracheostomy during ICU stay, ventilator-associated pneumonia, ICU length of stay, total duration of mechanical ventilation, and time from extubation to reintubation. Propensity score matching was performed to reduce selection bias between the HFNC and conventional oxygen therapy groups. Matching variables included age, sex, body mass index, diagnosis category, Glasgow Coma Scale score, airway protection status, duration of mechanical ventilation, and baseline gas exchange variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Flow Nasal Cannula Group | – | –Patients who received high-flow nasal cannula immediately after planned extubation according to routine clinical practice and the attending ICU physician's decision. HFNC was initiated after extubation with an initial flow rate of 60 L/min, and FiO2 was titrated to maintain SpO2 between 95% and 100%. HFNC was planned to continue for at least the first 24 hours after extubation and was then weaned according to clinical tolerance. |
| Conventional Oxygen Therapy Group | – | –Patients who received conventional oxygen therapy after planned extubation according to routine clinical practice and the attending ICU physician's decision. Oxygen was delivered via a standard nasal cannula or face mask, with oxygen flow adjusted to maintain SpO2 between 95% and 100%. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult post-neurosurgical patients with acute brain injury who were admitted to the Surgical Intensive Care Unit of Bach Mai Hospital, required invasive mechanical ventilation for at least 24 hours, and underwent planned extubation after meeting clinical readiness criteria. Patients received either high-flow nasal cannula or conventional oxygen therapy after extubation according to routine clinical practice and the attending ICU physician's decision.
Key inclusion criteria (8 listed)
- Patients aged 16 years or older.
- Admission to the Surgical Intensive Care Unit after neurosurgery for acute brain injury, including traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke, or other acute neurosurgical brain conditions.
- Requirement for invasive mechanical ventilation for at least 24 hours.
- Undergoing planned extubation after clinical assessment by the treating ICU team.
- Successful completion of a spontaneous breathing trial lasting 30 to 120 minutes.
Key exclusion criteria (7 listed)
- Pre-existing tracheostomy.
- Known upper airway obstruction, including airway stenosis or airway tumor.
- Suspected cerebrospinal fluid leak or complex skull base fracture.
- Unplanned self-extubation.
- Requirement for immediate prophylactic reintubation before initiation of post-extubation oxygen therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with treatment failure within 5 days after planned extubation
Time frame: Within 5 days after planned extubation
Treatment failure was defined as reintubation or escalation of respiratory support after planned extubation. Escalation of respiratory support included the need for non-invasive ventilation, rescue high-flow nasal cannula therapy in the conventional oxygen therapy group, or other clinically indicated escalation due to respiratory deterioration. Outcome assessment was based on bedside clinical monitoring, arterial blood gas analysis, respiratory status, neurological status, airway protection assessment, and ICU medical record review.
4 secondary outcomes
Proportion of patients requiring tracheostomy during ICU stay
Time frame: From planned extubation through ICU discharge, assessed up to 30 days after planned extubation
Incidence of ventilator-associated pneumonia during ICU stay
Time frame: From planned extubation through ICU discharge, assessed up to 30 days after planned extubation
Length of stay in the intensive care unit
Time frame: From ICU admission through ICU discharge, assessed up to 30 days after ICU admission
Time from planned extubation to reintubation
Time frame: From planned extubation through reintubation, assessed up to 5 days after planned extubation
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 10 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the main study results may be shared after publication of the primary results. Data sharing will be considered for researchers conducting systematic reviews, meta-analyses, or methodologically sound secondary analyses. Access will require approval by an ethics committee and a signed data sharing agreement with the study custodian or sponsor. Supporting Information: Study Protocol, Statistical Analysis Plan, Analytic Code, Informed Consent Form Time Frame: Beginning after publication of the main study results; end date not yet determined. Access Criteria: Requests may be submitted by qualified researchers for systematic reviews, meta-analyses, or approved secondary analyses. Data access will require ethics committee approval, a scientifically valid proposal, and completion of a data sharing agreement. Shared data will be de-identified. URL: Leave blank if there is no public repository. Email / Contact: haigmhshmu@gmail.com
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Brain Injury and Post-neurosurgical Status, run by Bach Mai Hospital at 1 site in Vietnam.
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 8 inclusion and 7 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 10 Sep 2026. 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 Vietnam. 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. 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?
Proportion of patients with treatment failure within 5 days after planned extubation (time frame: Within 5 days after planned extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.