High Flow Nasal CannulaNCT07159022
High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy
A study testing High Flow Nasal Cannula Oxygenation and Face Mask Oxygenation in people with High Flow Nasal Cannula and Body Roundness Index, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
During sedated gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce respiratory depression, airway obstruction, and decreased chest wall compliance. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- High Flow Nasal Cannula, Body Roundness Index
- What is being tested?
- High Flow Nasal Cannula Oxygenation and Face Mask Oxygenation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2025to 31 Jul 2026
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA class ≤Ⅲ
- Visceral obesity（body mass index≥28 and BRI ≥5.46）
- Patients who will undergo sedated gastroscopy
Who cannot join
- Life-threatening heart disease or acute myocardial infarction within 6 weeks
- Presence of pneumothorax or pulmonary bullae, pulmonary embolism, pulmonary oedema
- Upper respiratory tract infection
- Presence of tracheostomy
- Nasal or nasopharyngeal diseases
- Coagulation disorders or a tendency of nose bleeding
Show all 11Show fewer
- Pregnancy
- Recent (within 1 week) thoracic surgery
- Emergent procedure or surgery
- Allergy to drugs used during the procedure
- Unwillingness to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy: A Randomized Controlled Trial.
During sedated gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce respiratory depression, airway obstruction, and decreased chest wall compliance. Patients with obesity, especially visceral fat, have poor lung and chest wall compliance, lower lung capacity and functional residual capacity, and an unbalanced ventilation-to-perfusion ratio. Thus, obese patients are at a high risk of hypoxemia.
Increasing evidence supports the use of High-flow nasal cannula (HFNC) oxygenation in obese patients during sedated gastrointestinal endoscopy. Obesity, especially visceral obesity, is an established risk factor associated with all-cause mortality. Body roundness index (BRI) is a newer anthropometric measure associated with identification of high-risk individuals. Owing to the limited evidence, we designed this unblinded randomized controlled trial to assess whether HFNC, compared to standard mask oxygenation, improves oxygenation at the end of the procedure (primary endpoint) in patients with visceral obesity.
- Conditions
- High Flow Nasal Cannula, Body Roundness Index
- Being tested
- High Flow Nasal Cannula Oxygenation, Face Mask Oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal Cannula OxygenationProcedure or surgery
High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%
Face Mask OxygenationProcedure or surgery
conventional oxygen therapy will be administered through common mask with a flow up to 6 Liters per minute
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Cannula Oxygenation | Experimental | High Flow Nasal cannula is a system to deliver heated and humidified oxygen with an inspired oxygen fraction between 21 and 100% through large bore nasal cannula. The system delivers a flow up to 60 liters/min. Receives: Procedure: High Flow Nasal Cannula Oxygenation |
| Mask Oxygenation | Active comparator | Conventional Oxygenation will be administered through mask Receives: Procedure: Face Mask Oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxia
SpO2<90%
Measured: From sedation with propofol to the end of the gastroscopy
Secondary outcomes (4)
Incidence of subclinical respiratory depression
90%≤SpO2<95%
Measured: From sedation with propofol to the end of the gastroscopy
Severe hypoxia
SpO2<75% for any duration or 75%≤SpO2<90% for >60 s
Measured: From sedation with propofol to the end of the gastroscopy
Serious cardiac events
Hypotension: Mean arterial pressure (MAP) < 65 mmHg; hypertension: MAP > 90 mmHg
Measured: Through gastroscopy completion, an average of 10-15 minutes
Serious adverse respiratory events
Apnea, tracheospasm, larynx spasm
Measured: Through gastroscopy completion, an average of 10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start31 Aug 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Flow Nasal CannulaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159022
- Sponsor's protocol ID
- B2025-212
- Status last verified
- Nov 2025
- First submitted
- 27 Aug 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07159022
- Acronym / sponsor ID
- B2025-212
- Conditions
- High Flow Nasal Cannula, Body Roundness Index
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 8 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.
During sedated gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce respiratory depression, airway obstruction, and decreased chest wall compliance. Patients with obesity, especially visceral fat, have poor lung and chest wall compliance, lower lung capacity and functional residual capacity, and an unbalanced ventilation-to-perfusion ratio. Thus, obese patients are at a high risk of hypoxemia.
Increasing evidence supports the use of High-flow nasal cannula (HFNC) oxygenation in obese patients during sedated gastrointestinal endoscopy. Obesity, especially visceral obesity, is an established risk factor associated with all-cause mortality. Body roundness index (BRI) is a newer anthropometric measure associated with identification of high-risk individuals. Owing to the limited evidence, we designed this unblinded randomized controlled trial to assess whether HFNC, compared to standard mask oxygenation, improves oxygenation at the end of the procedure (primary endpoint) in patients with visceral obesity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Cannula Oxygenation | Experimental | Procedure: High Flow Nasal Cannula OxygenationHigh Flow Nasal cannula is a system to deliver heated and humidified oxygen with an inspired oxygen fraction between 21 and 100% through large bore nasal cannula. The system delivers a flow up to 60 liters/min. |
| Mask Oxygenation | Active comparator | Procedure: Face Mask OxygenationConventional Oxygenation will be administered through mask |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA class ≤Ⅲ
- Visceral obesity（body mass index≥28 and BRI ≥5.46）
- Patients who will undergo sedated gastroscopy
Key exclusion criteria (11 listed)
- Life-threatening heart disease or acute myocardial infarction within 6 weeks
- Presence of pneumothorax or pulmonary bullae, pulmonary embolism, pulmonary oedema
- Upper respiratory tract infection
- Presence of tracheostomy
- Nasal or nasopharyngeal diseases
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 OxygenationHigh Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94% | Procedure or surgery | High Flow Nasal Cannula Oxygenation |
| Face Mask Oxygenationconventional oxygen therapy will be administered through common mask with a flow up to 6 Liters per minute | Procedure or surgery | Mask Oxygenation |
Primary outcome
Incidence of hypoxia
Time frame: From sedation with propofol to the end of the gastroscopy
SpO2<90%
4 secondary outcomes
Incidence of subclinical respiratory depression
Time frame: From sedation with propofol to the end of the gastroscopy
Severe hypoxia
Time frame: From sedation with propofol to the end of the gastroscopy
Serious cardiac events
Time frame: Through gastroscopy completion, an average of 10-15 minutes
Serious adverse respiratory events
Time frame: Through gastroscopy completion, an average of 10-15 minutes
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 1 Dec 2025.
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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.
1 site 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 Face Mask Oxygenation in people with High Flow Nasal Cannula and Body Roundness Index, run by Shanghai Zhongshan Hospital at 1 site 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 3 inclusion and 11 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 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Wenling Zhao (+86-18321299017, zhao.wenling@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxia (time frame: From sedation with propofol to the end of the gastroscopy). 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 1 Dec 2025.