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
| Registry | NCT07664085 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 285 (Actual) |
| Sponsor | Bach Mai Hospital (Other) |
| Conditions | Acute Brain Injury, Post-neurosurgical Status, Extubation Failure, Postoperative Respiratory Complications, Reintubation |
| Dates | start 2025-01-01, primary completion 2025-12-31, completion 2026-01-30, first posted 2026-06-23, last updated 2026-09-10 |
| Locations | 1 site in Vietnam |
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All trials for Acute Brain Injury All trials for Post-neurosurgical Status
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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%. |
Sex: All, ages: 16 Years to any
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Bach Mai Hospital, Hanoi, Viet Nam. | Hanoi, Hanoi | Vietnam |