HypoxiaNCT06081647
The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure
A study testing the COMBO Endoscopy Oropharyngeal Airway and Regular Nasal Cannula in people with Hypoxia and Gastric Polyp, run by RenJi Hospital at 10 sites in China.
Trial summary
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Gastric Polyp, Colon Cancer
- What is being tested?
- the COMBO Endoscopy Oropharyngeal Airway and Regular Nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 10 sitesChina
- Study dates
- 27 Dec 2023to 27 Dec 2025
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18≤ Age ≤60.
- Patients undergoing gastroendoscopy and/or colonoscopy procedure.
- Patients have signed the informed consent form.
- The ASA classification ranges from I to II.
- The estimated duration of the procedure does not exceed 45 minutes.
Who cannot join
- Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement.
- Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs).
- Profound renal insufficiency necessitating preoperative dialysis.
- A confirmed severe liver dysfunction.
- Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy.
- Elevated intracranial pressure.
Show all 18Show fewer
- Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions.
- Fever, defined as a core body temperature exceeding 37.5 degrees Celsius.
- Pregnancy or lactation.
- Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape.
- Urgent surgical intervention.
- Polytrauma.
- Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively.
- BMI<18.5 or BMI>30.
- Patients with a documented history of substance abuse, specifically drugs and/or alcohol, within the two years preceding the commencement of the screening period. Substance abuse in this context is defined as consuming more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu.
- Patients with a history of mental and neurological disorders, including but not limited to depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, and myasthenia gravis.
- Presently engaged in concurrent participation in additional clinical trials.
- Patients considered ineligible by researchers for inclusion in this clinical trial.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
The First Affliated Hospital, Zhejiang University School Of Medicine
Hangzhou, Zhejiang
Diansan Su, Dr, +862168383702, diansansu@yahoo.com
- Recruiting
Shangdong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014
Jianbo Wu, Dr., jianbowu@126.com
- Recruiting
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi
Shibiao Chen, Dr, 13870982918
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Cunming Liu, Dr., 1335587409@qq.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jun Zhang, Dr., snapzhang@aliyun.com
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Jie Tian, Dr., 18616206596, vaseline2001@Hotmail.com
- Recruiting
Tongji Hospital Of Tongji University
Shanghai, Shanghai Municipality
Jianhui Liu, 13661452939, jianhuiliu-1246@163.com
- Recruiting
Xinhua Hospital Affliated To Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghia
Lai Jiang, Dr, 13651695976
- Recruiting
Tianjin Mediacal University General Hospital
Tianjin, Tianjin Municipality, 300052
Yonghao Yu, Dr., yuyonghao@126.com
- Recruiting
The First Affliated Hospital of Xi'an Jiangtong University
Xi’an, Shanxi, 710061
Qiang Wang, Dr., dr.wangqiang@xjtu.edu.cn
About this study
Official title: The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway Reduce the Incidence of Hypoxia in Patients Undergoing Gastrointestinal Endoscopy Sedated With Propofol.
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. 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. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing gastrointestinal endoscopy under propofol sedation.
- Conditions
- Hypoxia, Gastric Polyp, Colon Cancer, Esophageal Cancer
- Being tested
- the COMBO Endoscopy Oropharyngeal Airway, Regular Nasal Cannula
- Keywords
- the COMBO Endoscopy Oropharyngeal Airway, Hypoxia, Gastrointestinal Endoscopy, Propofol, Sedation
- Medical subject headings
- Hypoxia, Polyposis, Gastric, Colonic Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the COMBO Endoscopy Oropharyngeal AirwayDevice
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Regular Nasal CannulaDevice
Using regular nasal cannula for oxygenation.
| Study group | Role | What they receive |
|---|---|---|
| the COMBO Endoscopy Oropharyngeal Airway Group | Experimental | In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation. Receives: Device: the COMBO Endoscopy Oropharyngeal Airway |
| Regular Nasal Cannula Group | Active comparator | In this group, patients use the regular nasal cannula for oxygenation. Receives: Device: Regular Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypoxia
(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 hypoxia
(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 posted13 Oct 2023
- Study start27 Dec 2023
- Primary completion27 Dec 2025 (estimated)
- Study completion27 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081647
- Sponsor's protocol ID
- LY2023-159-B
- Status last verified
- Jun 2025
- First submitted
- 19 Sep 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data (including data dictionaries) and analysis codes generated in this study are available upon reasonable request. Additional documents, such as the study protocol and statistical analysis plan, can also be provided. Data will be accessible beginning 3 months after article publication for at least 5 years. Researchers seeking access must submit a request to the corresponding author for approval, which will be granted based on scientific merit and compliance with a data sharing agreement.
Publications
Zhang Y, Shi M, Qu Y, Cheng X, Zhang J, Guo S, Zheng Y, Su D. Efficacy and safety of the COMBO endoscopy oropharyngeal airway in gastrointestinal endoscopy: a study protocol for a multicenter randomized controlled trial. Trials. 2025 Dec 13;27(1):51. doi: 10.1186/s13063-025-09351-2.
PubMed 41390738
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway Reduce the Incidence of Hypoxia in Patients Undergoing Gastrointestinal Endoscopy Sedated With Propofol.
- ClinicalTrials.gov ID
- NCT06081647
- Acronym / sponsor ID
- LY2023-159-B
- Conditions
- Hypoxia, Gastric Polyp, Colon Cancer, Esophageal Cancer
- Keywords
- the COMBO Endoscopy Oropharyngeal Airway, Hypoxia, Gastrointestinal Endoscopy, Propofol, Sedation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 27 Dec 2025 (estimated)
- Study completion
- 27 Dec 2025 (estimated)
- First posted
- 13 Oct 2023 (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.
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. 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. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing gastrointestinal endoscopy under propofol sedation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the COMBO Endoscopy Oropharyngeal Airway Group | Experimental | Device: the COMBO Endoscopy Oropharyngeal AirwayIn this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation. |
| Regular Nasal Cannula Group | Active comparator | Device: Regular Nasal CannulaIn this group, patients use the regular nasal cannula for oxygenation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18≤ Age ≤60.
- Patients undergoing gastroendoscopy and/or colonoscopy procedure.
- Patients have signed the informed consent form.
- The ASA classification ranges from I to II.
- The estimated duration of the procedure does not exceed 45 minutes.
Key exclusion criteria (18 listed)
- Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement.
- Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs).
- Profound renal insufficiency necessitating preoperative dialysis.
- A confirmed severe liver dysfunction.
- Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy.
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 |
|---|---|---|
| the COMBO Endoscopy Oropharyngeal AirwayUsing the COMBO Endoscopy Oropharyngeal Airway for oxygenation. | Device | the COMBO Endoscopy Oropharyngeal Airway Group |
| Regular Nasal CannulaUsing regular nasal cannula for oxygenation. | Device | Regular Nasal Cannula Group |
Primary outcome
The incidence of hypoxia
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 hypoxia
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 25 Jun 2025.
- Derived from this study: PubMed 41390738Zhang Y, Shi M, Qu Y, Cheng X, Zhang J, Guo S, Zheng Y, Su D. Efficacy and safety of the COMBO endoscopy oropharyngeal airway in gastrointestinal endoscopy: a study protocol for a multicenter randomized controlled trial. Trials. 2025 Dec 13;27(1):51. doi: 10.1186/s13063-025-09351-2.
- Individual participant dataSharing planned: Yes. Deidentified participant data (including data dictionaries) and analysis codes generated in this study are available upon reasonable request. Additional documents, such as the study protocol and statistical analysis plan, can also be provided. Data will be accessible beginning 3 months after article publication for at least 5 years. Researchers seeking access must submit a request to the corresponding author for approval, which will be granted based on scientific merit and compliance with a data sharing agreement.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the COMBO Endoscopy Oropharyngeal Airway and Regular Nasal Cannula in people with Hypoxia and Gastric Polyp, run by RenJi Hospital at 10 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 18 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 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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, Dr. (+862168383702, 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 hypoxia (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?
On the ClinicalTrials.gov record for NCT06081647, which also lists 1 linked publication.
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 25 Jun 2025.