High-Flow Nasal Cannula After Extubation in Acute Brain Injury

NCT07664085 | Completed

• 1 other identifier: BM_2024_231
• Study Type: observational
• Target: 285
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 5 days after planned extubation

Secondary Outcomes (4)

• Proportion of patients requiring tracheostomy during ICU stay

  From planned extubation through ICU discharge, assessed up to 30 days after planned extubation

• Incidence of ventilator-associated pneumonia during ICU stay

  From planned extubation through ICU discharge, assessed up to 30 days after planned extubation

• Length of stay in the intensive care unit

  From ICU admission through ICU discharge, assessed up to 30 days after ICU admission

• Time from planned extubation to reintubation

  From planned extubation through reintubation, assessed up to 5 days after planned extubation

Study Arms (2)

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%.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bach Mai Hospital: lead

Study Sites (1)

Bach Mai Hospital, Hanoi, Viet Nam.

Hanoi, Hanoi, 00000, Vietnam

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director, Center for Anesthesia and Surgical Intensive Care

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 23, 2026
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 30, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified individual participant data and supporting documents will be available after publication of the main study results. There is no predetermined end date for data availability; requests will be considered according to institutional policies, ethics requirements, and data sharing agreements.
• Access Criteria: De-identified individual participant data may be shared with qualified researchers for systematic reviews, meta-analyses, or scientifically valid secondary analyses. Access will require submission of a research proposal, approval by an ethics committee when applicable, and a signed data sharing agreement with the study custodian or sponsor. Available materials may include de-identified participant data underlying the published results, the study protocol, statistical analysis plan, analytic code, and informed consent form. Requests should be sent to the study contact by email.

Locations

VN (1)