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High-Flow Nasal Cannula After Extubation in Acute Brain Injury

17 giugno 2026 aggiornato da: Nguyen Toan Thang, Bach Mai Hospital

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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

285

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Vietnam
    • Hanoi
      • Hanoi, Hanoi, Vietnam, 00000
        • Bach Mai Hospital, Hanoi, Viet Nam.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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%.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of patients with treatment failure within 5 days after planned extubation
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of patients requiring tracheostomy during ICU stay
Lasso di tempo: From planned extubation through ICU discharge, assessed up to 30 days after planned extubation
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.
From planned extubation through ICU discharge, assessed up to 30 days after planned extubation
Incidence of ventilator-associated pneumonia during ICU stay
Lasso di tempo: From planned extubation through ICU discharge, assessed up to 30 days after planned extubation
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.
From planned extubation through ICU discharge, assessed up to 30 days after planned extubation
Length of stay in the intensive care unit
Lasso di tempo: From ICU admission through ICU discharge, assessed up to 30 days after ICU admission
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.
From ICU admission through ICU discharge, assessed up to 30 days after ICU admission
Time from planned extubation to reintubation
Lasso di tempo: From planned extubation through reintubation, assessed up to 5 days after planned extubation
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.
From planned extubation through reintubation, assessed up to 5 days after planned extubation

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bach Mai Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2025

Completamento primario (Effettivo)

31 dicembre 2025

Completamento dello studio (Effettivo)

30 gennaio 2026

Date di iscrizione allo studio

Primo inviato

14 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 giugno 2026

Primo Inserito (Effettivo)

23 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BM_2024_231

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

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.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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