Awake Tracheal IntubationNCT07384494
High-flow Nasal Cannula Versus Conventional Oxygen During Awake Tracheal Intubation With Difficult Airways
A study testing High-Flow Nasal Cannula and Ligh-Flow Nasal Cannula in people with Awake Tracheal Intubation and Difficult Airway, run by Wenxian Li at 6 sites in China.
Trial summary
Study Background Airway management is one of the most fundamental and critical technical procedures in anesthesiology, critical care, and emergency medicine. Difficult airway management remains a major challenge in these fields, particularly when a "cannot intubate, cannot ventilate" scenario occurs during the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Awake Tracheal Intubation, Difficult Airway
- What is being tested?
- High-Flow Nasal Cannula and Ligh-Flow Nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 6 sitesChina
- Study dates
- 4 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Baoding No.1 Central Hospital
Baoding, Hebei
Xiaonan Zhao, MD., +86 15194969821, zhaoxiaonan2005@126.com
- Not yet recruiting
The First People's Hospital of Neijiang
Neijiang, Sichuan
Fei Jiang, MD., +86 18283236053, 1277636690@qq.com
- Recruiting
Pizhou Hospital of Traditional Chinese Medicine
Pizhou, Jiangsu
Yuanxin Yu, MD., +86 15862146631, 540160087@qq.com
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality
Yuan Han, PhD. MD., +86 021 643 771 34, yuan.han@fdeent.org
- Recruiting
South China Hospital of Shenzhen University
Shenzhen, Guangzhou
Yuancheng Hu, MD., +86 13244723668, 252203320@qq.com
- Recruiting
Wuwei People's Hospital
Wuwei, Gansu
Xiaojuan Li, MD., +86 18893755060, 1123390492@qq.com
About this study
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)
Study Background Airway management is one of the most fundamental and critical technical procedures in anesthesiology, critical care, and emergency medicine. Difficult airway management remains a major challenge in these fields, particularly when a "cannot intubate, cannot ventilate" scenario occurs during the induction of general anesthesia. Such events can rapidly lead to hypoxemia, resulting in brain injury or even death, and have become a significant source of anesthesia-related severe complications and medical disputes.
Awake tracheal intubation (ATI) is considered the gold standard for airway management in patients with anticipated difficult airways, as it preserves spontaneous breathing and thereby reduces the risk of catastrophic airway failure during anesthesia induction. However, despite routine supplemental oxygen administration, hypoxemia remains one of the most common and potentially serious complications during ATI. When low-flow oxygen therapy (<30 L/min) is used, the reported incidence of hypoxemia (SpO₂ ≤ 90%) ranges from 12% to 29%. Once hypoxemia occurs during ATI, it may not only interrupt the procedure, increase the number of intubation attempts, and reduce the likelihood of successful intubation, but also trigger serious cardiovascular events, thereby compromising patient safety.
Read more
High-flow nasal cannula (HFNC) oxygen therapy can deliver heated and humidified gas at flow rates of up to 70 L/min and improve oxygenation and ventilation through mechanisms such as anatomical dead space washout, reduction of work of breathing, and generation of continuous positive airway pressure. HFNC has been shown to improve oxygenation in a variety of medical and procedural settings. However, evidence regarding the role of HFNC during awake tracheal intubation remains controversial and of low quality. There is an urgent need for well-designed multicenter randomized controlled trials specifically focused on the ATI setting, using hypoxemic events as the primary outcome and applying strictly standardized procedures, to provide high-quality evidence on the effectiveness and safety of HFNC during ATI. Such evidence is essential to inform clinical practice and support future updates of airway management guidelines.
Study Hypothesis This study hypothesizes that, in patients with anticipated difficult airways undergoing ATI, HFNC is more effective in preventing intubation-related hypoxemic events than conventional low-flow nasal cannula oxygen therapy.
Study Objectives
Primary 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.
- Conditions
- Awake Tracheal Intubation, Difficult Airway
- Being tested
- High-Flow Nasal Cannula, Ligh-Flow Nasal Cannula
- Keywords
- Awake tracheal intubation, High-flow nasal cannula, Difficult airway, hypoxemia
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow Nasal CannulaDevice
A heated and humidified high-flow nasal oxygen therapy device（Fisher \& Paykel，East Tamaki，New Zealand） set at a flow rate of 40 L/min, an inspired oxygen fraction (FiO₂) of 100%, and a temperature of 37 °C.
Ligh-Flow Nasal CannulaDevice
Low-flow oxygen delivered via a disposable nasal cannula at a flow rate of 4 L/min.
| Study group | Role | What they receive |
|---|---|---|
| HFNC group | Experimental | 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. Receives: Device: High-Flow Nasal Cannula |
| LFNC group | Active comparator | 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. Receives: Device: Ligh-Flow Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxemia（SpO₂≤ 90%）
Measured: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
Secondary outcomes (10)
Incidence of SpO₂ ≤ 80%
Measured: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
Lowest SpO₂
Measured: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
Cumulative duration of hypoxemia
Measured: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
Number of hypoxemic episodes per participant (defined as the first occurrence of SpO₂ ≤ 90% after preoxygenation counted as one episode; subsequent episodes counted if SpO₂ returns to normal and then decreases again)
Measured: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
SpO₂ at the time of successful intubation
Measured: At the time of successful intubation up to 24 hours
End-tidal carbon dioxide (EtCO₂) at the time of successful intubation
Measured: At the time of successful intubation up to 24 hours
Proportion of participants requiring rescue interventions after the occurrence of hypoxemia
Measured: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
First-attempt intubation success rate
Measured: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
Awake tracheal intubation success rate
Measured: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
Intubation time
Defined as the duration from initiation of ATI to confirmation of successful intubation by end-tidal carbon dioxide
Measured: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start4 Feb 2026
- Primary completion4 Feb 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Awake Tracheal IntubationStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenxian Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wenxian Li, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384494
- Sponsor's protocol ID
- EENTFudan 2025155-1
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cascio RS, Kilmon CA. Pervasive developmental disorder, not otherwise specified: primary care perspectives. Nurse Pract. 1997 Jul;22(7):11, 15-6, 18 passim.
PubMed 9253013Law JA, Morris IR, Brousseau PA, de la Ronde S, Milne AD. The incidence, success rate, and complications of awake tracheal intubation in 1,554 patients over 12 years: an historical cohort study. Can J Anaesth. 2015 Jul;62(7):736-44. doi: 10.1007/s12630-015-0387-y. Epub 2015 Apr 24.
PubMed 25907462Ho AM, Chung DC, To EW, Karmakar MK. Total airway obstruction during local anesthesia in a non-sedated patient with a compromised airway. Can J Anaesth. 2004 Oct;51(8):838-41. doi: 10.1007/BF03018461.
PubMed 15470176Badiger S, John M, Fearnley RA, Ahmad I. Optimizing oxygenation and intubation conditions during awake fibre-optic intubation using a high-flow nasal oxygen-delivery system. Br J Anaesth. 2015 Oct;115(4):629-32. doi: 10.1093/bja/aev262. Epub 2015 Aug 7.
PubMed 26253608Vourc'h M, Huard D, Le Penndu M, Deransy R, Surbled M, Malidin M, Mahe PJ, Guitton C, Roquilly A, Malard O, Feuillet F, Rozec B, Asehnoune K. High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trial. EClinicalMedicine. 2023 May 22;60:101998. doi: 10.1016/j.eclinm.2023.101998. eCollection 2023 Jun.
PubMed 37251624Mangan CE, Borow L, Burtnett-Rubin MM, Egan V, Giuntoli RL, Mikuta JJ. Pregnancy outcome in 98 women exposed to diethylstilbestrol in utero, their mothers, and unexposed siblings. Obstet Gynecol. 1982 Mar;59(3):315-9.
PubMed 7078877Kinsella SM, Winton AL, Mushambi MC, Ramaswamy K, Swales H, Quinn AC, Popat M. Failed tracheal intubation during obstetric general anaesthesia: a literature review. Int J Obstet Anesth. 2015 Nov;24(4):356-74. doi: 10.1016/j.ijoa.2015.06.008. Epub 2015 Jun 30.
PubMed 26303751Heidegger T. Management of the Difficult Airway. N Engl J Med. 2021 May 13;384(19):1836-1847. doi: 10.1056/NEJMra1916801. No abstract available.
PubMed 33979490Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major 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. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
PubMed 21447488
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07384494
- Acronym / sponsor ID
- EENTFudan 2025155-1
- Conditions
- Awake Tracheal Intubation, Difficult Airway
- Keywords
- Awake tracheal intubation, High-flow nasal cannula, Difficult airway, hypoxemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Wenxian LiUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Feb 2026 (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.
Study Background Airway management is one of the most fundamental and critical technical procedures in anesthesiology, critical care, and emergency medicine. Difficult airway management remains a major challenge in these fields, particularly when a "cannot intubate, cannot ventilate" scenario occurs during the induction of general anesthesia. Such events can rapidly lead to hypoxemia, resulting in brain injury or even death, and have become a significant source of anesthesia-related severe complications and medical disputes.
Awake tracheal intubation (ATI) is considered the gold standard for airway management in patients with anticipated difficult airways, as it preserves spontaneous breathing and thereby reduces the risk of catastrophic airway failure during anesthesia induction. However, despite routine supplemental oxygen administration, hypoxemia remains one of the most common and potentially serious complications during ATI. When low-flow oxygen therapy (<30 L/min) is used, the reported incidence of hypoxemia (SpO₂ ≤ 90%) ranges from 12% to 29%. Once hypoxemia occurs during ATI, it may not only interrupt the procedure, increase the number of intubation attempts, and reduce the likelihood of successful intubation, but also trigger serious cardiovascular events, thereby compromising patient safety.
High-flow nasal cannula (HFNC) oxygen therapy can deliver heated and humidified gas at flow rates of up to 70 L/min and improve oxygenation and ventilation through mechanisms such as anatomical dead space washout, reduction of work of breathing, and generation of continuous positive airway pressure. HFNC has been shown to improve oxygenation in a variety of medical and procedural settings. However, evidence regarding the role of HFNC during awake tracheal intubation remains controversial and of low quality. There is an urgent need for well-designed multicenter randomized controlled trials specifically focused on the ATI setting, using hypoxemic events as the primary outcome and applying strictly standardized procedures, to provide high-quality evidence on the effectiveness and safety of HFNC during ATI. Such evidence is essential to inform clinical practice and support future updates of airway management guidelines.
Study Hypothesis This study hypothesizes that, in patients with anticipated difficult airways undergoing ATI, HFNC is more effective in preventing intubation-related hypoxemic events than conventional low-flow nasal cannula oxygen therapy.
Study Objectives
Primary 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC group | Experimental | Device: High-Flow Nasal CannulaDuring 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. |
| LFNC group | Active comparator | Device: Ligh-Flow Nasal CannulaDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| High-Flow Nasal CannulaA heated and humidified high-flow nasal oxygen therapy device（Fisher \& Paykel，East Tamaki，New Zealand） set at a flow rate of 40 L/min, an inspired oxygen fraction (FiO₂) of 100%, and a temperature of 37 °C. | Device | HFNC group |
| Ligh-Flow Nasal CannulaLow-flow oxygen delivered via a disposable nasal cannula at a flow rate of 4 L/min. | Device | LFNC group |
Primary outcome
Incidence of hypoxemia（SpO₂≤ 90%）
Time frame: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
10 secondary outcomes
Incidence of SpO₂ ≤ 80%
Time frame: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
Lowest SpO₂
Time frame: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
Cumulative duration of hypoxemia
Time frame: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
Number of hypoxemic episodes per participant (defined as the first occurrence of SpO₂ ≤ 90% after preoxygenation counted as one episode; subsequent episodes counted if SpO₂ returns to normal and then decreases again)
Time frame: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
SpO₂ at the time of successful intubation
Time frame: At the time of successful intubation up to 24 hours
End-tidal carbon dioxide (EtCO₂) at the time of successful intubation
Time frame: At the time of successful intubation up to 24 hours
Proportion of participants requiring rescue interventions after the occurrence of hypoxemia
Time frame: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
First-attempt intubation success rate
Time frame: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
Awake tracheal intubation success rate
Time frame: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
Intubation time
Time frame: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 9253013Cascio RS, Kilmon CA. Pervasive developmental disorder, not otherwise specified: primary care perspectives. Nurse Pract. 1997 Jul;22(7):11, 15-6, 18 passim.
- Background: PubMed 25907462Law JA, Morris IR, Brousseau PA, de la Ronde S, Milne AD. The incidence, success rate, and complications of awake tracheal intubation in 1,554 patients over 12 years: an historical cohort study. Can J Anaesth. 2015 Jul;62(7):736-44. doi: 10.1007/s12630-015-0387-y. Epub 2015 Apr 24.
- Background: PubMed 15470176Ho AM, Chung DC, To EW, Karmakar MK. Total airway obstruction during local anesthesia in a non-sedated patient with a compromised airway. Can J Anaesth. 2004 Oct;51(8):838-41. doi: 10.1007/BF03018461.
- Background: PubMed 26253608Badiger S, John M, Fearnley RA, Ahmad I. Optimizing oxygenation and intubation conditions during awake fibre-optic intubation using a high-flow nasal oxygen-delivery system. Br J Anaesth. 2015 Oct;115(4):629-32. doi: 10.1093/bja/aev262. Epub 2015 Aug 7.
- Background: PubMed 37251624Vourc'h M, Huard D, Le Penndu M, Deransy R, Surbled M, Malidin M, Mahe PJ, Guitton C, Roquilly A, Malard O, Feuillet F, Rozec B, Asehnoune K. High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trial. EClinicalMedicine. 2023 May 22;60:101998. doi: 10.1016/j.eclinm.2023.101998. eCollection 2023 Jun.
- Background: PubMed 7078877Mangan CE, Borow L, Burtnett-Rubin MM, Egan V, Giuntoli RL, Mikuta JJ. Pregnancy outcome in 98 women exposed to diethylstilbestrol in utero, their mothers, and unexposed siblings. Obstet Gynecol. 1982 Mar;59(3):315-9.
- Background: PubMed 26303751Kinsella SM, Winton AL, Mushambi MC, Ramaswamy K, Swales H, Quinn AC, Popat M. Failed tracheal intubation during obstetric general anaesthesia: a literature review. Int J Obstet Anesth. 2015 Nov;24(4):356-74. doi: 10.1016/j.ijoa.2015.06.008. Epub 2015 Jun 30.
- Background: PubMed 33979490Heidegger T. Management of the Difficult Airway. N Engl J Med. 2021 May 13;384(19):1836-1847. doi: 10.1056/NEJMra1916801. No abstract available.
- Background: PubMed 21447488Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major 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. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
- Individual participant dataSharing planned: No
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Flow Nasal Cannula and Ligh-Flow Nasal Cannula in people with Awake Tracheal Intubation and Difficult Airway, run by Wenxian Li at 6 sites 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenxian Li, PhD. MD. (+86 021 643 771 34, wenxian.li@fdeent.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxemia（SpO₂≤ 90%） (time frame: From initiation of awake tracheal intubation to completion of successful tracheal intubation confirmed by end-tidal carbon dioxide (EtCO₂), assessed up to 30 minutes.). 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 NCT07384494, which also lists 9 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 28 Jul 2026.