HypoxiaNCT04500392
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity
A study testing High-flow nasal cannula oxygenation 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 during gastrointestinal endoscopes sedated with propofol and sufentanil, especially in obese people. In the present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the incidence of hypoxia among obesity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypoxia, Gastric Cancer, Esophagus Cancer
- What is being tested?
- High-flow nasal cannula oxygenation and Regular nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 3 sitesChina
- Study dates
- 6 May 2021to Jan 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing gastrointestinal endoscopes
- age≥18 years old and ≤70 years old
- patients or family members signed informed consent form
- ASA classification I-II
- BMI≥ 28kg/m²
Who cannot join
- Coagulation disorders or a tendency of nose bleeding;
- An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;
- Severe aortic stenosis or mitral stenosis;
- Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;
- Acute myocardial infarction in the last 6 months;
- Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability;
Show all 16Show fewer
- Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);
- Increased intracranial pressure;
- ASA classification Ⅲ-Ⅳ ;
- Mouth, nose, or throat infection;
- Liver and kidney disease
- Fever, defined as core body temperature > 37.5℃;
- Pregnancy, breastfeeding or positive pregnancy test;
- Emergency procedure;
- Patients or family members refused to participate
- Mental disorders and people without civil capacity
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Shanghai Tongji Hospital
Shanghai, Shanghai, China, 200065
Xiaoqing Zhang, M.S., xq_820175@163.com
- Recruiting
Shanghai Oriental Hospital
Shanghai, Shanghai, China, 200120
Xiangrui Wang, Dr., wangxr2010@yahoo.com
- Recruiting
Renji hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai, China, 200127
Zhang Yuanyuan, B.S., +862168383702, 2630643807@qq.com
About this study
Official title: High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity: a Randomized Multicenter Clinical Trial
Hypoxia is the most common adverse event during gastrointestinal endoscopes sedated with propofol and sufentanil, especially in obese people. In the present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the incidence of hypoxia among obesity.
- Conditions
- Hypoxia, Gastric Cancer, Esophagus Cancer, Polyp of Colon, Colon Cancer
- Being tested
- High-flow nasal cannula oxygenation, Regular nasal cannula
- Keywords
- Hypoxia, Gastrointestinal endoscopes, High-flow nasal cannula Oxygenation
- Medical subject headings
- Hypoxia, Stomach Neoplasms, Esophageal Neoplasms, Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannula oxygenationDevice
Oxygen is supplied with a high-flow nasal cannula oxygenation device#the flow is up to 60L/min
Regular nasal cannulaDevice
Oxygen is supplied with a regular nasal cannula #the flow is up to 6L/min
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Oxygen(up to 6L/min) supplied with a regular nasal catheter Receives: Device: Regular nasal cannula |
| High-flow nasal cannula group | Experimental | Oxygen(up to 60L/min) supplied with high-flow nasal cannula 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 hypoxia
(75% ≤ SpO2 < 90% for <60 s)
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours]
Secondary outcomes (3)
The incidence of subclinical respiratory depression
(90% ≤ SpO2 < 95%)
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The incidence of severe hypoxia
(SpO2 < 75% for any duration or 75% < SpO2 < 90% for >/=60 s)
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start6 May 2021
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (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.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai Oriental Hospital, Tongji University School of Medicine
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
- Investigators
- Diansan Su, Dr., Principal investigator, Renji Hospital, Shanghai Jiaotong University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500392
- Sponsor's protocol ID
- HFNOIO
- Status last verified
- Jan 2024
- First submitted
- 2 Aug 2020
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang L, Zhang Y, Han D, Wei M, Zhang J, Cheng X, Zhang Y, Shi M, Song Z, Wang X, Zhang X, Su D. Effect of high flow nasal cannula oxygenation on incidence of hypoxia during sedated gastrointestinal endoscopy in patients with obesity: multicentre randomised controlled trial. BMJ. 2025 Feb 11;388:e080795. doi: 10.1136/bmj-2024-080795.
PubMed 39933757
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity: a Randomized Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT04500392
- Acronym / sponsor ID
- HFNOIO
- Conditions
- Hypoxia, Gastric Cancer, Esophagus Cancer, Polyp of Colon, Colon Cancer
- Keywords
- Hypoxia, Gastrointestinal endoscopes, High-flow nasal cannula Oxygenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai Oriental Hospital, Tongji University School of Medicine
- Study start
- 6 May 2021 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 5 Aug 2020 (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 during gastrointestinal endoscopes sedated with propofol and sufentanil, especially in obese people. In the present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the incidence of hypoxia among obesity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Regular nasal cannulaOxygen(up to 6L/min) supplied with a regular nasal catheter |
| High-flow nasal cannula group | Experimental | Device: High-flow nasal cannula oxygenationOxygen(up to 60L/min) supplied with high-flow nasal cannula |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients undergoing gastrointestinal endoscopes
- age≥18 years old and ≤70 years old
- patients or family members signed informed consent form
- ASA classification I-II
- BMI≥ 28kg/m²
Key exclusion criteria (16 listed)
- Coagulation disorders or a tendency of nose bleeding;
- An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;
- Severe aortic stenosis or mitral stenosis;
- Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;
- Acute myocardial infarction in the last 6 months;
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 cannula oxygenationOxygen is supplied with a high-flow nasal cannula oxygenation device#the flow is up to 60L/min | Device | High-flow nasal cannula group |
| Regular nasal cannulaOxygen is supplied with a regular nasal cannula #the flow is up to 6L/min | Device | Control group |
Primary outcome
The incidence of hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours]
(75% ≤ SpO2 < 90% for <60 s)
3 secondary outcomes
The incidence of subclinical respiratory depression
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The incidence of severe hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Derived from this study: PubMed 39933757Wang L, Zhang Y, Han D, Wei M, Zhang J, Cheng X, Zhang Y, Shi M, Song Z, Wang X, Zhang X, Su D. Effect of high flow nasal cannula oxygenation on incidence of hypoxia during sedated gastrointestinal endoscopy in patients with obesity: multicentre randomised controlled trial. BMJ. 2025 Feb 11;388:e080795. doi: 10.1136/bmj-2024-080795.
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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. This study is not recruiting at the moment.
Diansan Su, Dr. principal investigator
Renji Hospital, Shanghai Jiaotong University, Shanghai, China
3 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 oxygenation 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 16 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. 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?
Results are not available in the source record.
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 of 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 NCT04500392, 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 11 Jan 2024.