High-flow nasal oxygen versus regular oxygen during awake intubation for difficult airways

High-Flow Nasal Cannula Versus Conventional Oxygen to Prevent Hypoxaemia During Awake Tracheal Intubation: A Multicentre, Open-Label, Randomised Controlled Trial (OXYOPTI-ATI)

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 336 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (Academic / other)
• Locations: 6 sites (Wuwei, Gansu and 5 other locations)
• Trial ID: NCT07384494 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Wuwei, Gansu and 5 other locations

• Wuwei People's Hospital — Wuwei, Gansu, China (Recruiting)
• South China Hospital of Shenzhen University — Shenzhen, Guangzhou, China (Recruiting)
• Baoding No.1 Central Hospital — Baoding, Hebei, China (Not_yet_recruiting)
• Pizhou Hospital of Traditional Chinese Medicine — Pizhou, Jiangsu, China (Recruiting)
• Eye & ENT Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• The First People's Hospital of Neijiang — Neijiang, Sichuan, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Wenxian Li, PhD. MD.

Conditions Awake Tracheal Intubation; Difficult Airway; Awake tracheal intubation; High-flow nasal cannula; Difficult airway; hypoxemia