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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objective: To evaluate the effectiveness of high-flow nasal cannula oxygen therapy compared with conventional low-flow nasal cannula oxygen therapy in preventing hypoxemia during ATI in patients with anticipated difficult airways. Secondary

Objectives: To assess the effects of high-flow nasal cannula oxygen therapy versus conventional low-flow nasal cannula oxygen therapy on procedural outcomes of awake tracheal intubation, including the rate of interventions required after hypoxemia, first-attempt intubation success rate, number of intubation attempts, overall ATI success rate, intubation time, and the incidence of adverse events. Study Methods This study is a multicenter, randomized controlled clinical trial. Adult patients undergoing ATI will be recruited from six tertiary hospitals in China. Participants will be randomly assigned to receive either high-flow nasal cannula oxygen therapy or conventional low-flow nasal cannula oxygen therapy throughout the intubation procedure. The study will compare the incidence of hypoxemia between the two groups and further evaluate intubation success rates, intubation time, the need for rescue interventions following hypoxemia, and the incidence of adverse events.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Baoding No.1 Central Hospital
NOT_YET_RECRUITING
Baoding
The First People's Hospital of Neijiang
NOT_YET_RECRUITING
Neijiang
Pizhou Hospital of Traditional Chinese Medicine
RECRUITING
Pizhou
Eye & ENT Hospital of Fudan University
RECRUITING
Shanghai
South China Hospital of Shenzhen University
RECRUITING
Shenzhen
Wuwei People's Hospital
RECRUITING
Wuwei
Contact Information
Primary
Wenxian Li, PhD. MD.
wenxian.li@fdeent.org
+86 021 643 771 34
Time Frame
Start Date: 2026-02-04
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 336
Treatments
Experimental: HFNC group
During awake tracheal intubation, participants receive heated and humidified high-flow nasal cannula oxygen therapy at a flow rate of 40 L/min, FiO₂ of 100%, and a temperature of 37 °C, starting before the procedure and continuing until successful intubation is confirmed by the presence of end-tidal carbon dioxide.
Active_comparator: LFNC group
During awake tracheal intubation, participants receive oxygen via a disposable nasal cannula at a flow rate of 4 L/min, starting before the procedure and continuing until successful intubation is confirmed by the presence of end-tidal carbon dioxide.
Related Therapeutic Areas
Sponsors
Leads: Wenxian Li

This content was sourced from clinicaltrials.gov