An interventional study of the COMBO Endoscopy Oropharyngeal Airway and Regular Nasal Cannula in Hypoxia, Gastric Polyp and Colon Cancer, sponsored by RenJi Hospital. Recruiting at 10 sites in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Prevention
Among 14 studies in Hypoxia by RenJi Hospital — 5 open to participants now, 5 under way, none of them phase 3. Hypoxia · RenJi Hospital.
Among the 14 studies in Hypoxia by RenJi Hospital, this one is the 6th largest by planned enrollment, is one of 2 that started in 2023, is one of 14 with no phase, and was the 13th registered.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
Browse Hypoxia studies →5 of the 14 studies in Hypoxia by RenJi Hospital are open now, in 1 country. Recruiting first, the newest first:
RenJi Hospital · Sites in China
RenJi Hospital · Sites in China
RenJi Hospital · Sites in China
RenJi Hospital · Sites in China
By country, each count listing its studies:
Of the 125 Hypoxia studies recruiting now, 53 (42%) set no upper age limit and 45 (36%) stop at 75 or younger; 15 take children under 18; 33 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 2 started in 2023.
This study's planned enrollment of 1,200 is above the median of 45 across 769 interventional studies indexed under Hypoxia.
Median enrollment 980 across the 14 interventional studies. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Hypoxia by RenJi Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Device: the COMBO Endoscopy Oropharyngeal Airway
In this group, patients use the regular nasal cannula for oxygenation.
Device: Regular Nasal Cannula
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Using regular nasal cannula for oxygenation.
The incidence of hypoxia
(75% ≤ SpO2 \< 90% for \<60 s)
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of sub-clinical respiratory depression
(90% ≤ SpO2 \< 95%)
Time frame: 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)
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Plan to share: 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.
No publications or documents are linked to this record.
Started Dec 2023 (actual). Primary completion is estimated for Dec 2025, 24 months after the start.
Of 321 non-industry interventional studies with no phase under Hypoxia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 24 months is above that.
Counting every sponsor, half of 351 studies reached it within 12 months; a quarter within 3 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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