HypoxemiaNCT07175155
Combination of COMBO Endoscopy Oropharyngeal Airway and HFNC Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients
A study testing COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation and High-Flow Nasal Cannula Oxygenation in people with Hypoxemia and Esophageal Cancer, run by Zhejiang University at 5 sites in China.
Trial summary
Hypoxaemia during sedated gastrointestinal endoscopy exceeds 40 % in morbidly obese (BMI ≥ 35 kg m-²) patients. High-flow nasal cannula alone often fails because of persistent airway collapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia, Esophageal Cancer, Morbidly Obese Patients
- What is being tested?
- COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation and High-Flow Nasal Cannula Oxygenation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 5 sitesChina
- Study dates
- 24 Oct 2025to 20 Aug 2027
- 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
- Age ≥ 18 years.
- BMI ≥ 35 kg/m².
- Patients undergoing gastroscopy or gastrointestinal endoscopy.
- The estimated duration of the procedure does not exceed 45 minutes.
- Patients have signed the informed consent form.
Who cannot join
- Coagulation disorders or bleeding tendency (e.g., oral/nasal bleeding risk, mucosal injury, oropharyngeal obstruction) making oropharyngeal airway placement unsafe or unfeasible.
- Active upper respiratory tract infection (oral, nasal, or pharyngeal), or fever (core temperature >37.5°C).
- Chronic obstructive pulmonary disease or other acute/chronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air.
- Severe organ dysfunction, including: Cardiac insufficiency (<4 METs), Severe renal insufficiency (requiring dialysis), Diagnosed severe hepatic insufficiency, Increased intracranial pressure, ASA physical status ≥ IV.
- Confirmed pregnancy or current breastfeeding.
- Known allergy to sedatives (e.g., propofol) or medical adhesives.
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- Multiple traumatic injuries.
- Current participation in another clinical trial.
- Other conditions deemed unsuitable by the investigator.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100000
Dongxin Wang, Dr, dxwang65@bjmu.edu.cn
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Diansan Su, Dr, +8618616514088, diansansu@yahoo.com
- Recruiting
Jinjiang Municipal Hospital
Jinjiang, Fujian, 362200
Fusheng Xu, Dr, +86 13860742856, 936612081@qq.com
- Recruiting
The Fifth Affiliated Hospital of Wenzhou Medical University
Lishui, Zhejiang, 310000
Zhilan Dou, +8618857809608, 1024734445@qq.com
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 310000
Lijun Zhu, +8613586117093, zhulijun@enzemed.com
About this study
Official title: Combination of COMBO Endoscopy Oropharyngeal Airway and High-flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients: a Multicenter, Randomized, Controlled Clinical Trial
Hypoxaemia during sedated gastrointestinal endoscopy exceeds 40 % in morbidly obese (BMI ≥ 35 kg m-²) patients. High-flow nasal cannula alone often fails because of persistent airway collapse. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management.The purpose of this study is to investigate whether the combination of the COMBO Endoscopy Oropharyngeal Airway and High-Flow Nasal Cannula oxygenation reduces the incidence of hypoxemia in this population.
- Conditions
- Hypoxemia, Esophageal Cancer, Morbidly Obese Patients, Gastric Cancer
- Being tested
- COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation, High-Flow Nasal Cannula Oxygenation
- Keywords
- COMBO Endoscopy Oropharyngeal Airway, Hypoxemia, Sedation, Gastrointestinal Endoscopy, high-flow nasal cannula
- Medical subject headings
- Hypoxia, Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula OxygenationDevice
Using the COMBO endoscopy oropharyngeal airway with High-Flow Nasal Cannula Oxygenation in sedated gastrointestinal endoscopy for morbidly obese patients
High-Flow Nasal Cannula OxygenationDevice
In this group, patients use high-flow nasal cannula oxygenation
| Study group | Role | What they receive |
|---|---|---|
| COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation | Experimental | In this group, patients use the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation Receives: Device: COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation |
| High-Flow Nasal Cannula Oxygenation | Active comparator | In this group, patients use the High-Flow Nasal Cannula Oxygenation Receives: Device: High-Flow Nasal Cannula Oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypoxemia
75% ≤ SpO2 < 90% for <60 s
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Secondary outcomes (2)
The incidence of sub-clinical respiratory depression
90% ≤ SpO2 < 95%
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of severe hypoxaemia
SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start24 Oct 2025
- Primary completion20 Aug 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diansan Su, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175155
- Sponsor's protocol ID
- ZJU2025C140
- Status last verified
- Oct 2025
- First submitted
- 9 Sep 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of COMBO Endoscopy Oropharyngeal Airway and High-flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients: a Multicenter, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07175155
- Acronym / sponsor ID
- ZJU2025C140
- Conditions
- Hypoxemia, Esophageal Cancer, Morbidly Obese Patients, Gastric Cancer
- Keywords
- COMBO Endoscopy Oropharyngeal Airway, Hypoxemia, Sedation, Gastrointestinal Endoscopy, high-flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 16 Sep 2025 (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.
Hypoxaemia during sedated gastrointestinal endoscopy exceeds 40 % in morbidly obese (BMI ≥ 35 kg m-²) patients. High-flow nasal cannula alone often fails because of persistent airway collapse. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management.The purpose of this study is to investigate whether the combination of the COMBO Endoscopy Oropharyngeal Airway and High-Flow Nasal Cannula oxygenation reduces the incidence of hypoxemia in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation | Experimental | Device: COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula OxygenationIn this group, patients use the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation |
| High-Flow Nasal Cannula Oxygenation | Active comparator | Device: High-Flow Nasal Cannula OxygenationIn this group, patients use the High-Flow Nasal Cannula Oxygenation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- BMI ≥ 35 kg/m².
- Patients undergoing gastroscopy or gastrointestinal endoscopy.
- The estimated duration of the procedure does not exceed 45 minutes.
- Patients have signed the informed consent form.
Key exclusion criteria (9 listed)
- Coagulation disorders or bleeding tendency (e.g., oral/nasal bleeding risk, mucosal injury, oropharyngeal obstruction) making oropharyngeal airway placement unsafe or unfeasible.
- Active upper respiratory tract infection (oral, nasal, or pharyngeal), or fever (core temperature >37.5°C).
- Chronic obstructive pulmonary disease or other acute/chronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air.
- Severe organ dysfunction, including: Cardiac insufficiency (<4 METs), Severe renal insufficiency (requiring dialysis), Diagnosed severe hepatic insufficiency, Increased intracranial pressure, ASA physical status ≥ IV.
- Confirmed pregnancy or current breastfeeding.
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 |
|---|---|---|
| COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula OxygenationUsing the COMBO endoscopy oropharyngeal airway with High-Flow Nasal Cannula Oxygenation in sedated gastrointestinal endoscopy for morbidly obese patients | Device | COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation |
| High-Flow Nasal Cannula OxygenationIn this group, patients use high-flow nasal cannula oxygenation | Device | High-Flow Nasal Cannula Oxygenation |
Primary outcome
The incidence of hypoxemia
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
75% ≤ SpO2 < 90% for <60 s
2 secondary outcomes
The incidence of sub-clinical respiratory depression
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of severe hypoxaemia
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
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 11 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation and High-Flow Nasal Cannula Oxygenation in people with Hypoxemia and Esophageal Cancer, run by Zhejiang University at 5 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 5 inclusion and 9 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 Diansan Su, Chief Physician (+8618616514088, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hypoxemia (time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2026.