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High-Flow Nasal Cannula After Extubation in Acute Brain Injury

17. Juni 2026 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

285

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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%.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of patients with treatment failure within 5 days after planned extubation
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of patients requiring tracheostomy during ICU stay
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Januar 2025

Primärer Abschluss (Tatsächlich)

31. Dezember 2025

Studienabschluss (Tatsächlich)

30. Januar 2026

Studienanmeldedaten

Zuerst eingereicht

14. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Juni 2026

Zuerst gepostet (Tatsächlich)

23. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

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.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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