High-flow nasal oxygen versus regular oxygen during awake intubation for difficult airways
Official title: High-Flow Nasal Cannula Versus Conventional Oxygen to Prevent Hypoxaemia During Awake Tracheal Intubation: A Multicentre, Open-Label, Randomised Controlled Trial (OXYOPTI-ATI)
Run by Eye & ENT Hospital of Fudan University · NCT07384494 · Data updated 2026-11-12
This trial will test whether high-flow nasal oxygen helps adults with anticipated difficult airways keep their oxygen levels safer during awake tracheal intubation compared with conventional low-flow oxygen.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 336 (estimated) |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 6 sites (Wuwei, Gansu and 5 other locations) |
| Status | Recruiting |
| Started | February 4, 2026 |
| Main results expected | February 4, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 28, 2026 |
| Trial ID | NCT07384494 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18 years) with an anticipated difficult airway who are planned for awake tracheal intubation and can provide informed consent.
✕Probably not a fit
Patients with contraindications to high-flow nasal cannula (severe nasal obstruction, recent nasal/skull base surgery, skull base fracture, active epistaxis), hemodynamic instability, pregnancy, or those already in another interventional trial are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with an anticipated difficult airway who are scheduled for awake tracheal intubation will be assigned to receive either high-flow nasal cannula oxygen or conventional low-flow nasal oxygen during the procedure. The protocol preserves spontaneous breathing and monitors oxygenation throughout intubation, with hypoxemia incidence and related complications as key outcomes. Standard airway management techniques are used alongside the assigned oxygen therapy to compare safety and stability during awake intubation. Data will be collected at multiple participating hospitals in China and analyzed to determine differences in desaturation and procedure-related adverse events.
Why it matters
Potential benefit: If successful, this approach could reduce episodes of low oxygen during awake intubation and lower the risk of serious complications from hypoxemia.
How similar studies have gone: Prior clinical work has suggested high-flow nasal oxygen can reduce desaturation during airway management and apneic periods, but evidence specifically in awake tracheal intubation is limited and not yet definitive.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presence of an anticipated difficult airway; * Planned awake tracheal intubation; * Age ≥ 18 years; * Willingness to participate in the study and provision of written informed consent. Exclusion Criteria: * Contraindications to HFNC use, such as severe nasal obstruction or deformity, recent (within 3 months) nasal or skull base surgery, skull base fracture, or active epistaxis; * Hemodynamic instability, defined as a mean arterial pressure (MAP) \< 65 mmHg or the need for vasoactive medications to maintain blood pressure; * Pregnancy; * Current participation in another interventional clinical trial.
Where it's running
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Wuwei People's Hospital
Wuwei, Gansu, China Recruiting -
South China Hospital of Shenzhen University
Shenzhen, Guangzhou, China Recruiting -
Pizhou Hospital of Traditional Chinese Medicine
Pizhou, Jiangsu, China Recruiting -
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting -
Baoding No.1 Central Hospital
Baoding, Hebei, China Not yet recruiting -
The First People's Hospital of Neijiang
Neijiang, Sichuan, China Not yet recruiting
Study contacts
- Study coordinator: Wenxian Li, PhD. MD.
- Email: wenxian.li@fdeent.org
- Phone: +86 021 643 771 34
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.