High Flow Oxygen TherapyNCT07257016
HFTO Via Tracheal Intubation in Neurocritical Patients
A study testing HFTO and PSV in people with High Flow Oxygen Therapy and Neuro ICU, run by Capital Medical University at 1 site in China.
Trial summary
Neurocritical patients often require prolonged invasive ventilation due to impaired respiratory drive and airway protection deficits. While early weaning reduces complications and costs, these patients frequently pass spontaneous breathing trials (SBT) yet remain intubated solely for airway protection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Flow Oxygen Therapy, Neuro ICU
- What is being tested?
- HFTO and PSV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 28 Apr 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Post-neurosurgical or brain injury patients with stable intracranial status (Glasgow Coma Scale ≥ 9, Richmond Agitation-Sedation Scale score -2 to +1).
- Successful completion of a 30-minute T-piece spontaneous breathing trial (per standard SBT failure criteria).
- Poor airway protection capacity (STAGE score < 6) necessitates ongoing intubation for respiratory support, as determined by the attending physician.
- Signed informed consent (by patient or legal representative).
Who cannot join
- Contraindications to esophageal pressure monitoring (e.g., esophageal varices, recent esophageal surgery).
- History of chronic respiratory diseases (e.g., COPD, severe asthma).
- Chronic heart failure (NYHA class III-IV) or severe arrhythmia.
- Body Mass Index (BMI) > 30 kg/m².
- Pregnancy.
- Anticipated need for tracheostomy without extubation attempt
- Withdrawal of life-sustaining treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-Flow Oxygen Therapy Via Tracheal Intubation in Neurocritical Patients
Neurocritical patients often require prolonged invasive ventilation due to impaired respiratory drive and airway protection deficits. While early weaning reduces complications and costs, these patients frequently pass spontaneous breathing trials (SBT) yet remain intubated solely for airway protection.
Current practice maintains low-level pressure support ventilation (5-8 cmH₂O) to offset endotracheal tube resistance. However, prolonged ventilation increases risks of ventilator-associated pneumonia (VAP) and diaphragm dysfunction. Emerging evidence suggests appropriately sized tubes may not substantially increase work of breathing (WOB).
Read more
High-flow oxygen therapy (HFOT) delivers heated, humidified oxygen at high flow rates, reducing WOB and improving oxygenation and comfort. While validated for tracheostomized patients, HFOT via tracheal intubation (HFOT-TI) remains unstudied in neurocritical populations during early weaning.
This study aims to evaluate the safety and feasibility of HFOT-TI in neurocritical patients who have passed SBT but require ongoing airway protection.
Read the detailed description
Neurocritical patients, including those with traumatic brain injury, stroke, or intracranial hemorrhage, often require prolonged mechanical ventilation due to impaired respiratory drive or airway protection needs. Weaning these patients from invasive ventilation involves two key stages: liberation from mechanical support and extubation. Early weaning reduces complications, accelerates recovery, and lowers healthcare costs. Clinical guidelines advocate early weaning assessments for patients ventilated for over 24 hours, followed by spontaneous breathing trials (SBT) to confirm readiness for independent breathing. While patients passing SBT are typically extubated promptly, neurocritical patients often face delayed extubation due to impaired consciousness or inadequate airway protection, despite adequate respiratory function. In these cases, the tracheal tube primarily ensures airway protection rather than ventilatory support.
Traditionally, low-level ventilatory support (e.g., pressure support of 5-8 cmH₂O) is used to counter the inspiratory resistance of the tracheal tube and provide humidified gas. However, prolonged ventilation, even at minimal levels, may increase risks such as ventilator-associated pneumonia and diaphragm dysfunction. Evidence indicates that appropriately sized tracheal tubes may not substantially increase the work of breathing (WOB), and some patients can compensate for this resistance without ventilatory support.
High-flow oxygen therapy (HFOT), delivered via nasal cannula or tracheostomy, provides heated, humidified oxygen at high flow rates, enhancing oxygenation, reducing WOB, and improving patient comfort. Emerging evidence supports its role in facilitating weaning in tracheostomized patients and during SBT in intubated patients. However, the safety and feasibility of HFOT via tracheal intubation (HFOT-TI) in neurocritical patients during early weaning remain largely unexplored. Given the prolonged airway protection needs in this population, HFOT-TI may serve as an effective bridge to extubation, potentially minimizing prolonged ventilatory support and associated complications.
Investigators aimed to evaluate the safety and feasibility of HFOT-TI in neurocritical patients who have passed SBT but require ongoing airway protection. Investigators assessed changes in respiratory parameters and safety outcomes.
- Conditions
- High Flow Oxygen Therapy, Neuro ICU
- Being tested
- HFTO, PSV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFTODevice
Use a high-flow oxygen therapy system connected to the endotracheal tube via a dedicated adapter. Initial settings: Flow rate 40 L/min, FiO₂ titrated to maintain patient SpO₂ ≥ 95%.
PSVDevice
Continue low-level pressure support ventilation using a mechanical ventilator. Parameter settings: Pressure support (PS) 5-8 cmH₂O, PEEP 5 cmH₂O, FiO₂ ≤ 0.40.
| Study group | Role | What they receive |
|---|---|---|
| HFTO | Experimental | Patients with delayed extubation receiving high-flow tracheal oxygen therapy. Receives: Device: HFTO |
| PSV | Active comparator | Patients with delayed extubation receiving low-level pressure support ventilation. Receives: Device: PSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTPes
PTPes is defined as the area enclosed by the Pcw and Pes curves during the inspiratory phase, multiplied by the respiratory rate.
Measured: 48 hours
Secondary outcomes (2)
Pmus
Pmus is defined as the maximum difference between the chest wall recoil pressure (Pcw) and the esophageal pressure (Pes) during inspiration.
Measured: 48 hours
Ventilator-Free Days
Ventilator-Free Days during the first 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start15 Dec 2025
- Primary completion27 Feb 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for High Flow Oxygen TherapyStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Guangqiang, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257016
- Sponsor's protocol ID
- HX-B-2025-016
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: through clinical trials
Publications
Girard TD, Alhazzani W, Kress JP, Ouellette DR, Schmidt GA, Truwit JD, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Patel S, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Wilson KC, Morris PE; ATS/CHEST Ad Hoc Committee on Liberation from Mechanical Ventilation in Adults. An Official American Thoracic Society/American College of Chest Physicians Clinical Practice Guideline: Liberation from Mechanical Ventilation in Critically Ill Adults. Rehabilitation Protocols, Ventilator Liberation Protocols, and Cuff Leak Tests. Am J Respir Crit Care Med. 2017 Jan 1;195(1):120-133. doi: 10.1164/rccm.201610-2075ST.
PubMed 27762595Janssen ML, Weller D, Endeman H, Heunks LM, Wils EJ. Physiological Effects of High-Flow Tracheal Oxygen in Tracheostomized Patients Weaning From Mechanical Ventilation. Respir Care. 2024 Sep 26;69(10):1336-1344. doi: 10.4187/respcare.11755.
PubMed 38772682
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Flow Oxygen Therapy Via Tracheal Intubation in Neurocritical Patients
- ClinicalTrials.gov ID
- NCT07257016
- Acronym / sponsor ID
- HX-B-2025-016
- Conditions
- High Flow Oxygen Therapy, Neuro ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 2 Dec 2025 (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.
Neurocritical patients often require prolonged invasive ventilation due to impaired respiratory drive and airway protection deficits. While early weaning reduces complications and costs, these patients frequently pass spontaneous breathing trials (SBT) yet remain intubated solely for airway protection.
Current practice maintains low-level pressure support ventilation (5-8 cmH₂O) to offset endotracheal tube resistance. However, prolonged ventilation increases risks of ventilator-associated pneumonia (VAP) and diaphragm dysfunction. Emerging evidence suggests appropriately sized tubes may not substantially increase work of breathing (WOB).
High-flow oxygen therapy (HFOT) delivers heated, humidified oxygen at high flow rates, reducing WOB and improving oxygenation and comfort. While validated for tracheostomized patients, HFOT via tracheal intubation (HFOT-TI) remains unstudied in neurocritical populations during early weaning.
This study aims to evaluate the safety and feasibility of HFOT-TI in neurocritical patients who have passed SBT but require ongoing airway protection.
Detailed description
Neurocritical patients, including those with traumatic brain injury, stroke, or intracranial hemorrhage, often require prolonged mechanical ventilation due to impaired respiratory drive or airway protection needs. Weaning these patients from invasive ventilation involves two key stages: liberation from mechanical support and extubation. Early weaning reduces complications, accelerates recovery, and lowers healthcare costs. Clinical guidelines advocate early weaning assessments for patients ventilated for over 24 hours, followed by spontaneous breathing trials (SBT) to confirm readiness for independent breathing. While patients passing SBT are typically extubated promptly, neurocritical patients often face delayed extubation due to impaired consciousness or inadequate airway protection, despite adequate respiratory function. In these cases, the tracheal tube primarily ensures airway protection rather than ventilatory support.
Traditionally, low-level ventilatory support (e.g., pressure support of 5-8 cmH₂O) is used to counter the inspiratory resistance of the tracheal tube and provide humidified gas. However, prolonged ventilation, even at minimal levels, may increase risks such as ventilator-associated pneumonia and diaphragm dysfunction. Evidence indicates that appropriately sized tracheal tubes may not substantially increase the work of breathing (WOB), and some patients can compensate for this resistance without ventilatory support.
High-flow oxygen therapy (HFOT), delivered via nasal cannula or tracheostomy, provides heated, humidified oxygen at high flow rates, enhancing oxygenation, reducing WOB, and improving patient comfort. Emerging evidence supports its role in facilitating weaning in tracheostomized patients and during SBT in intubated patients. However, the safety and feasibility of HFOT via tracheal intubation (HFOT-TI) in neurocritical patients during early weaning remain largely unexplored. Given the prolonged airway protection needs in this population, HFOT-TI may serve as an effective bridge to extubation, potentially minimizing prolonged ventilatory support and associated complications.
Investigators aimed to evaluate the safety and feasibility of HFOT-TI in neurocritical patients who have passed SBT but require ongoing airway protection. Investigators assessed changes in respiratory parameters and safety outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFTO | Experimental | Device: HFTOPatients with delayed extubation receiving high-flow tracheal oxygen therapy. |
| PSV | Active comparator | Device: PSVPatients with delayed extubation receiving low-level pressure support ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Post-neurosurgical or brain injury patients with stable intracranial status (Glasgow Coma Scale ≥ 9, Richmond Agitation-Sedation Scale score -2 to +1).
- Successful completion of a 30-minute T-piece spontaneous breathing trial (per standard SBT failure criteria).
- Poor airway protection capacity (STAGE score < 6) necessitates ongoing intubation for respiratory support, as determined by the attending physician.
- Signed informed consent (by patient or legal representative).
Key exclusion criteria (7 listed)
- Contraindications to esophageal pressure monitoring (e.g., esophageal varices, recent esophageal surgery).
- History of chronic respiratory diseases (e.g., COPD, severe asthma).
- Chronic heart failure (NYHA class III-IV) or severe arrhythmia.
- Body Mass Index (BMI) > 30 kg/m².
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFTOUse a high-flow oxygen therapy system connected to the endotracheal tube via a dedicated adapter. Initial settings: Flow rate 40 L/min, FiO₂ titrated to maintain patient SpO₂ ≥ 95%. | Device | HFTO |
| PSVContinue low-level pressure support ventilation using a mechanical ventilator. Parameter settings: Pressure support (PS) 5-8 cmH₂O, PEEP 5 cmH₂O, FiO₂ ≤ 0.40. | Device | PSV |
Primary outcome
PTPes
Time frame: 48 hours
PTPes is defined as the area enclosed by the Pcw and Pes curves during the inspiratory phase, multiplied by the respiratory rate.
2 secondary outcomes
Pmus
Time frame: 48 hours
Ventilator-Free Days
Time frame: 28 days
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 4 May 2026.
- Background: PubMed 27762595Girard TD, Alhazzani W, Kress JP, Ouellette DR, Schmidt GA, Truwit JD, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Patel S, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Wilson KC, Morris PE; ATS/CHEST Ad Hoc Committee on Liberation from Mechanical Ventilation in Adults. An Official American Thoracic Society/American College of Chest Physicians Clinical Practice Guideline: Liberation from Mechanical Ventilation in Critically Ill Adults. Rehabilitation Protocols, Ventilator Liberation Protocols, and Cuff Leak Tests. Am J Respir Crit Care Med. 2017 Jan 1;195(1):120-133. doi: 10.1164/rccm.201610-2075ST.
- Background: PubMed 38772682Janssen ML, Weller D, Endeman H, Heunks LM, Wils EJ. Physiological Effects of High-Flow Tracheal Oxygen in Tracheostomized Patients Weaning From Mechanical Ventilation. Respir Care. 2024 Sep 26;69(10):1336-1344. doi: 10.4187/respcare.11755.
- Individual participant dataSharing planned: Yes. through clinical trials
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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?
A study testing HFTO and PSV in people with High Flow Oxygen Therapy and Neuro ICU, run by Capital Medical University at 1 site in China.
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 5 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 4 May 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 China. 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?
PTPes (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07257016, which also lists 2 linked publications.
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 4 May 2026.