HypoxiaNASONCT05405530
Nasal Mask Kit in Gastrointestinal Endoscopy
A study testing nasal mask oxygen kit and regular nasal cannula in people with Hypoxia and Gastric Cancer, run by RenJi Hospital at 3 sites in China.
Trial summary
Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol. The nasal mask oxygen kit has good sealing to ensure an adequate oxygen supply and is convenient and economical.The aim of this randomized study was to determine whether the nasal mask oxygen kit reduces the incidence of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypoxia, Gastric Cancer, Gastric Polyp
- What is being tested?
- nasal mask oxygen kit and regular nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,204 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2022to 6 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- 18≤ Age ≤60
- patients undergoing combined gastroendoscopy and colonoscopy procedure
- patients signed informed consent form
- ASA classification I-II
- Estimated procedure time <=45min
Who cannot join
- Coagulation disorders or a tendency of nose bleeding
- Diagnosed heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.)
- Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy)
- hypoxia (SpO2< 90 % )
- Upper respiratory tract infection
- increased intracranial pressure
Show all 12Show fewer
- Fever (core body temperature >37.5 ℃)
- Pregnancy, breastfeeding, or positive pregnancy test
- Emergency procedure or surgery
- Multiple trauma
- Allergy to propofol or tape and adhesives
- BMI<18.5 or BMI>30
Trial locations and contacts
3 sites in 1 country.
China3 sites
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
About this study
Official title: Nasal Mask Oxygen Reduces the Incidence of Hypoxia Undergoing Gastrointestinal Endoscopy Under Propofol Sedation: a Multicenter Randomized Controlled Trial
Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol. The nasal mask oxygen kit has good sealing to ensure an adequate oxygen supply and is convenient and economical.The aim of this randomized study was to determine whether the nasal mask oxygen kit reduces the incidence of hypoxia in gastrointestinal endoscopes procedures.
- Conditions
- Hypoxia, Gastric Cancer, Gastric Polyp, Colon Polyp, Colon Cancer, Esophageal Cancer
- Being tested
- nasal mask oxygen kit, regular nasal cannula
- Keywords
- nasal mask, Hypoxia, Gastrointestinal endoscopy, Propofol, Capnographic Monitoring
- Medical subject headings
- Hypoxia, Stomach Neoplasms, Polyposis, Gastric, Colonic Polyps, Colonic Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal mask oxygen kitDevice
Using the nasal mask oxygen kit for oxygenation.
regular nasal cannulaDevice
Using nasal cannula for oxygenation.
| Study group | Role | What they receive |
|---|---|---|
| nasal mask oxygen group | Experimental | In this group, patients use the nasal mask oxygen kit for oxygenation. Receives: Device: nasal mask oxygen kit |
| 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 (3)
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
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
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 posted6 Jun 2022
- Study start1 Sep 2022
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
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.
- 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
- 1,204 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital, First Affiliated Hospital of Kunming Medical University
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405530
- Sponsor's protocol ID
- RenJiH-2022-01-04
- Acronym
- NASO
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2022
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Cheng X, Zhang X, Zhang J, Hu Z, Zhang J, Lian Q, Ding X, He Y, Shi M, Zhang Y, Tian M, Zheng H, Li Z, Wang Y, Yu W, Shao J, Su D. Efficacy of a nasal mask oxygen kit versus regular nasal cannula in sedated gastrointestinal endoscopy: a multicentre, randomised clinical trial. BMJ Open Gastroenterol. 2025 Jul 7;12(1):e001834. doi: 10.1136/bmjgast-2025-001834.
PubMed 40623715
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Mask Oxygen Reduces the Incidence of Hypoxia Undergoing Gastrointestinal Endoscopy Under Propofol Sedation: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05405530
- Acronym / sponsor ID
- NASO / RenJiH-2022-01-04
- Conditions
- Hypoxia, Gastric Cancer, Gastric Polyp, Colon Polyp, Colon Cancer, Esophageal Cancer
- Keywords
- nasal mask, Hypoxia, Gastrointestinal endoscopy, Propofol, Capnographic Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,204 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital, First Affiliated Hospital of Kunming Medical University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 6 Jun 2022 (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 is the most common adverse event in gastrointestinal endoscopes sedated with propofol. The nasal mask oxygen kit has good sealing to ensure an adequate oxygen supply and is convenient and economical.The aim of this randomized study was to determine whether the nasal mask oxygen kit reduces the incidence of hypoxia in gastrointestinal endoscopes procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal mask oxygen group | Experimental | Device: nasal mask oxygen kitIn this group, patients use the nasal mask oxygen kit 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
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18≤ Age ≤60
- patients undergoing combined gastroendoscopy and colonoscopy procedure
- patients signed informed consent form
- ASA classification I-II
- Estimated procedure time <=45min
Key exclusion criteria (12 listed)
- Coagulation disorders or a tendency of nose bleeding
- Diagnosed heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.)
- Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy)
- hypoxia (SpO2< 90 % )
- Upper respiratory tract infection
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 |
|---|---|---|
| nasal mask oxygen kitUsing the nasal mask oxygen kit for oxygenation. | Device | nasal mask oxygen group |
| regular nasal cannulaUsing 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)
3 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
The incidence of other adverse events
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Derived from this study: PubMed 40623715Cheng X, Zhang X, Zhang J, Hu Z, Zhang J, Lian Q, Ding X, He Y, Shi M, Zhang Y, Tian M, Zheng H, Li Z, Wang Y, Yu W, Shao J, Su D. Efficacy of a nasal mask oxygen kit versus regular nasal cannula in sedated gastrointestinal endoscopy: a multicentre, randomised clinical trial. BMJ Open Gastroenterol. 2025 Jul 7;12(1):e001834. doi: 10.1136/bmjgast-2025-001834.
- Individual participant dataSharing planned: Yes
Related trials for Hypoxia
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Recruiting
Methodological Study of Exercise and Hypoxic Conditions in Healthy Subjects
Healthy Subjects (HS), Exercise
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal mask oxygen kit and regular nasal cannula in people with Hypoxia and Gastric Cancer, run by RenJi Hospital at 3 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 12 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: finished, as of the sponsor's last update on 5 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 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT05405530, 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 5 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.