Pervasive developmental disorder, not otherwise specified: primary care perspectives.
R S Cascio, C A Kilmon
https://pubmed.ncbi.nlm.nih.gov/9253013Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07384494
High-Flow Nasal Cannula Versus Conventional Oxygen to Prevent Hypoxaemia During Awake Tracheal Intubation: A Multicentre, Open-Label, Randomised Controlled Trial (OXYOPTI-ATI)
Led by Wenxian Li · Updated on 2026-03-17
336
Participants Needed
6
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Airway management is a vital procedure in anesthesiology, critical care, and emergency medicine, especially for patients with anticipated difficult airways undergoing awake tracheal intubation (ATI). This trial examines whether high-flow nasal cannula (HFNC) oxygen therapy can better prevent hypoxemia—low blood oxygen levels—during ATI compared to conventional low-flow nasal cannula oxygen therapy. Hypoxemia during ATI can interrupt the procedure, lower intubation success, and cause serious complications, making this an important study to improve safety. Participants are randomly assigned to one of two groups: one receiving heated and humidified HFNC oxygen at 40 L/min with 100% oxygen starting before ATI and continuing until intubation is confirmed; the other group receives low-flow nasal oxygen at 4 L/min under the same timing. The study is conducted across multiple centers and focuses on comparing the incidence of hypoxemia and other related outcomes during ATI. During the study, participants will be closely monitored from the start of ATI until successful intubation is confirmed by end-tidal carbon dioxide measurement, up to 30 minutes. Researchers will track the occurrence and severity of hypoxemia, intubation success rates, time needed for intubation, and any adverse events. This thorough monitoring aims to provide clear evidence on the effectiveness and safety of HFNC oxygen therapy in this critical setting.
CONDITIONS
Brief Title
High-flow Nasal Cannula Versus Conventional Oxygen During Awake Tracheal Intubation With Difficult Airways
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Presence of an anticipated difficult airway
- Planned awake tracheal intubation
- Age 18 years or older
- Willingness to participate and provide written informed consent
You will not qualify if you...
- Contraindications to high-flow nasal cannula such as severe nasal obstruction, recent nasal or skull base surgery within 3 months, skull base fracture, or active nosebleeds
- Hemodynamic instability with mean arterial pressure below 65 mmHg or requiring vasoactive medications
- Pregnancy
- Current participation in another interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Up to 30 minutes
Participants receive oxygen therapy during awake tracheal intubation using either a high-flow nasal cannula or a low-flow nasal cannula until successful intubation is confirmed by the presence of end-tidal carbon dioxide.
1 procedure visit (in-person)
Trial Site Locations
Total: 6 locations
1
Wuwei People's Hospital
Wuwei, Gansu, China
Actively Recruiting
2
South China Hospital of Shenzhen University
Shenzhen, Guangzhou, China
Actively Recruiting
3
Baoding No.1 Central Hospital
Baoding, Hebei, China
Not Yet Recruiting
4
Pizhou Hospital of Traditional Chinese Medicine
Pizhou, Jiangsu, China
Actively Recruiting
5
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
6
The First People's Hospital of Neijiang
Neijiang, Sichuan, China
Not Yet Recruiting
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Research Team
W
Wenxian Li, PhD. MD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Anthony M H Ho, David C Chung, Edward W H To...
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S Badiger, M John, R A Fearnley...
https://pubmed.ncbi.nlm.nih.gov/26253608High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trial.
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https://pubmed.ncbi.nlm.nih.gov/26303751Management of the Difficult Airway.
Thomas Heidegger
https://pubmed.ncbi.nlm.nih.gov/33979490Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia.
T M Cook, N Woodall, C Frerk...
https://pubmed.ncbi.nlm.nih.gov/21447488