HypoxiaNCT06585306
High-flow Nasal Oxygen Therapy in Obese Patients Undergoing Sedativegastrointestinal Endoscopy
A study testing jaw lift, increasing oxygen flow, mask ventilation, intubation in people with Hypoxia and Obesity, run by XiaoLiang Wang at 1 site in China.
Trial summary
Obese patients often have fat accumulation in the head and neck, increased soft tissue in the oropharynx, decreased lung compliance, decreased lung volume and residual volume, and some obese patients also suffer from obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia, Obesity, Gastrostomy
- What is being tested?
- jaw lift, increasing oxygen flow, mask ventilation, intubation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2024to 20 Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing sedative gastrointestinal endoscopy
- Aged over 18.
- ASA classification I-III
- BMI>28kg/m2
- Compliance with ethics, patient willing to participate in the trial, signed informed consent form
Who cannot join
- Contraindications for endoscopic procedures or patients refusing sedation/anesthesia.
- Patients with allergies to propofol, eggs, soybeans, or milk.
- Patients with gastrointestinal obstruction and gastric emptying disorders.
- Patients with acute pharyngitis, tonsillitis, and upper respiratory tract infections.
- 5: Patients with acute exacerbations of respiratory diseases such as asthma, bronchitis, and COPD. 6. Patients with acute arrhythmias and severe heart disease (congenital, valvular disease). 7. Patients requiring replacement therapy for severe liver or kidney dysfunction.
- 8. Patients with severe mental illnesses requiring medication to control symptoms.
- 9. Patients with moderate to severe anemia, coagulation disorders, and hematological diseases. 10. Patients with severe nasal congestion caused by nasal cavity lesions. 11. Pregnant and lactating patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Safety of High-flow Nasal Oxygen Therapy With Different Flow Rates in Obese Patients Undergoing Sedative Gastrointestinal Endoscopy
Obese patients often have fat accumulation in the head and neck, increased soft tissue in the oropharynx, decreased lung compliance, decreased lung volume and residual volume, and some obese patients also suffer from obstructive sleep apnea. Therefore, obese patients may experience hypoxemia during sedative gastroscopy. High-flow nasal cannula oxygen therapy (HFNC) can provide patients with high-flow (20-70 L/min) and adjustable oxygen concentration (21%-100%) through a special nasal prong catheter. It has the function of warming and humidifying the air, relieving pressure on the nasal mucosa, maintaining airway patency and moisture, reducing the risk of nasal bleeding. In addition, HFNC can generate positive airway pressure (3-7 cmH2O), increase end-expiratory volume, help with alveolar recruitment, prevent atelectasis, and reduce shunts. The flow rate of HFNC is positively correlated with the nasopharyngeal pressure. At a flow rate of 50 L/min, the nasopharyngeal pressure can exceed 3 cmH2O. Obese patients are prone to upper airway obstruction under sedation or anesthesia. The use of HFNC at 70 L/min perioperatively can reduce hypoxemia in patients, but discomfort in the nasopharynx may occur at this flow rate. The optimal flow rate for clinical use of HFNC has not been established. Meta-analysis shows that when the oxygen flow rate during painless esophagogastroduodenoscopy is greater than 30 L/min, it can significantly reduce the incidence of hypoxemia in patients. Therefore, for obese patients undergoing painless esophagogastroduodenoscopy, the investigators propose using HFNC at three different flow rates: 30 L/min, 50 L/min, and 70 L/min, to provide guidance on the optimal flow rate for clinical use of HFNC.
Read the detailed description
Gastrointestinal endoscopy is a common method for screening and diagnosing digestive diseases, with approximately 23 million cases performed in China annually. However, this invasive procedure can cause patients to experience pain, nausea, vomiting, and coughing. With the advancement of comfortable medical technology, more patients are opting for painless gastroscopy, which offers higher comfort and satisfaction levels for patients and facilitates the operation for endoscopists.
During sedative gastroscopy, nasal cannula oxygen therapy is commonly used to maintain oxygen levels, with oxygen flow rates typically ranging from 2-6L/min. The most common complication during the procedure is hypoxia. For obese patients, the risk of hypoxemia is increased due to fat accumulation in the head and neck, increased soft tissue in the oropharynx, decreased lung compliance and volumes, and potential obstructive sleep apnea. Therefore, appropriate oxygen therapy is crucial in preventing complications in obese patients during gastroscopy.
High-flow nasal cannula oxygen therapy (HFNC) is a new ventilation method that provides patients with high-flow oxygen (20-70L/min) through a special nasal cannula, with adjustable oxygen concentration (21%-100%) and warming and humidifying functionalities. HFNC can alleviate mucosal ciliary pressure, maintain airway patency and moisture, reduce the risk of nasal bleeding, and generate positive airway pressure, aiding in alveolar recruitment and preventing atelectasis.
Studies have shown that HFNC can reduce the occurrence of hypoxia during painless gastroscopy compared to standard oxygen therapy. The positive airway pressure provided by HFNC is crucial in reducing upper airway obstruction and improving ventilation. The optimal flow rate for HFNC in obese patients undergoing gastroscopy remains unclear, but starting at 30L/min has shown benefits in reducing the risk of hypoxemia without significant discomfort.
Therefore, the investigators propose to investigate the effects of HFNC at flow rates of 30L/min, 50L/min, and 70L/min during painless gastroscopy in obese patients to determine the optimal flow rate that minimizes the risk of hypoxemia without causing discomfort.
- Conditions
- Hypoxia, Obesity, Gastrostomy
- Being tested
- jaw lift, increasing oxygen flow, mask ventilation, intubation
- Keywords
- Obese patients, sedative gastrointestinal endoscopy, HFNC
- Medical subject headings
- Hypoxia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
jaw lift, increasing oxygen flow, mask ventilation, intubationBehavioural
When patients develop hypoxemia, the above interventions are sequentially employed to improve their oxygenation status.
| Study group | Role | What they receive |
|---|---|---|
| HFNC30L/min | Experimental | patients pre-oxygenation with pure oxygen at 30L/min for 1 minute, followed by sedation with slightly slow but steady breathing, disappearance of eyelash reflex, and continued oxygen flow at 30 L/min Receives: Behavioral: jaw lift, increasing oxygen flow, mask ventilation, intubation |
| HFNC50L/min | Experimental | patients pre-oxygenation with pure oxygen at 30L/min for 1 minute, followed by sedation with slightly slow but steady breathing, adjustment of oxygen flow to 50L/min after disappearance of eyelash reflex. Receives: Behavioral: jaw lift, increasing oxygen flow, mask ventilation, intubation |
| HFNC70L/min | Experimental | patients pre-oxygenation with pure oxygen at 30L/min for 1 minute, followed by sedation with slightly slow but steady breathing, adjustment of oxygen flow to 70L/min after disappearance of eyelash reflex. Receives: Behavioral: jaw lift, increasing oxygen flow, mask ventilation, intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hypoxia
75% ≤ SpO2 < 90% for <60 second
Measured: 6 mintues before gastrointestinal completion
Secondary outcomes (6)
incidences of subclinical respiratory depression and severe hypoxia
(90% ≤ SpO2 < 95%) and (SpO2 < 75% for any duration or 75% ≤ SpO2 < 90% for ≥60 second)
Measured: 6 mintues before gastrointestinal completion
adverse event
vomit
Measured: 6 mintues before gastrointestinal completion
airway obstruction
Patients had glossoptosis, excessive oropharynx secretion, laryngeal spasm, or bronchospasm
Measured: 6 mintues before gastrointestinal completion
paradoxical response
Patients displayed unpredictable movement, overexcitement, and delirium after sedation with propofol
Measured: 6 mintues before gastrointestinal completion
airway intervention
jaw lift, increase the flow of oxygen,mask ventilation,Intubation
Measured: 6 mintues before gastrointestinal completion
waist circumfnrence, neck circumference
measure neck circumference, messure neck circumference
Measured: before gastrointestinal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start23 Oct 2024
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 864 participants (actual)
Sponsor and investigators
- Lead sponsor
- XiaoLiang Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XiaoLiang Wang, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Xiaoliang Wang, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585306
- Sponsor's protocol ID
- KY20240419-07
- Status last verified
- Sep 2024
- First submitted
- 14 May 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety of High-flow Nasal Oxygen Therapy With Different Flow Rates in Obese Patients Undergoing Sedative Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT06585306
- Acronym / sponsor ID
- KY20240419-07
- Conditions
- Hypoxia, Obesity, Gastrostomy
- Keywords
- Obese patients, sedative gastrointestinal endoscopy, HFNC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 864 participants (actual)
- Lead sponsor
- XiaoLiang WangUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 5 Sep 2024 (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.
Obese patients often have fat accumulation in the head and neck, increased soft tissue in the oropharynx, decreased lung compliance, decreased lung volume and residual volume, and some obese patients also suffer from obstructive sleep apnea. Therefore, obese patients may experience hypoxemia during sedative gastroscopy. High-flow nasal cannula oxygen therapy (HFNC) can provide patients with high-flow (20-70 L/min) and adjustable oxygen concentration (21%-100%) through a special nasal prong catheter. It has the function of warming and humidifying the air, relieving pressure on the nasal mucosa, maintaining airway patency and moisture, reducing the risk of nasal bleeding. In addition, HFNC can generate positive airway pressure (3-7 cmH2O), increase end-expiratory volume, help with alveolar recruitment, prevent atelectasis, and reduce shunts. The flow rate of HFNC is positively correlated with the nasopharyngeal pressure. At a flow rate of 50 L/min, the nasopharyngeal pressure can exceed 3 cmH2O. Obese patients are prone to upper airway obstruction under sedation or anesthesia. The use of HFNC at 70 L/min perioperatively can reduce hypoxemia in patients, but discomfort in the nasopharynx may occur at this flow rate. The optimal flow rate for clinical use of HFNC has not been established. Meta-analysis shows that when the oxygen flow rate during painless esophagogastroduodenoscopy is greater than 30 L/min, it can significantly reduce the incidence of hypoxemia in patients. Therefore, for obese patients undergoing painless esophagogastroduodenoscopy, the investigators propose using HFNC at three different flow rates: 30 L/min, 50 L/min, and 70 L/min, to provide guidance on the optimal flow rate for clinical use of HFNC.
Detailed description
Gastrointestinal endoscopy is a common method for screening and diagnosing digestive diseases, with approximately 23 million cases performed in China annually. However, this invasive procedure can cause patients to experience pain, nausea, vomiting, and coughing. With the advancement of comfortable medical technology, more patients are opting for painless gastroscopy, which offers higher comfort and satisfaction levels for patients and facilitates the operation for endoscopists.
During sedative gastroscopy, nasal cannula oxygen therapy is commonly used to maintain oxygen levels, with oxygen flow rates typically ranging from 2-6L/min. The most common complication during the procedure is hypoxia. For obese patients, the risk of hypoxemia is increased due to fat accumulation in the head and neck, increased soft tissue in the oropharynx, decreased lung compliance and volumes, and potential obstructive sleep apnea. Therefore, appropriate oxygen therapy is crucial in preventing complications in obese patients during gastroscopy.
High-flow nasal cannula oxygen therapy (HFNC) is a new ventilation method that provides patients with high-flow oxygen (20-70L/min) through a special nasal cannula, with adjustable oxygen concentration (21%-100%) and warming and humidifying functionalities. HFNC can alleviate mucosal ciliary pressure, maintain airway patency and moisture, reduce the risk of nasal bleeding, and generate positive airway pressure, aiding in alveolar recruitment and preventing atelectasis.
Studies have shown that HFNC can reduce the occurrence of hypoxia during painless gastroscopy compared to standard oxygen therapy. The positive airway pressure provided by HFNC is crucial in reducing upper airway obstruction and improving ventilation. The optimal flow rate for HFNC in obese patients undergoing gastroscopy remains unclear, but starting at 30L/min has shown benefits in reducing the risk of hypoxemia without significant discomfort.
Therefore, the investigators propose to investigate the effects of HFNC at flow rates of 30L/min, 50L/min, and 70L/min during painless gastroscopy in obese patients to determine the optimal flow rate that minimizes the risk of hypoxemia without causing discomfort.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFNC30L/min | Experimental | Behavioral: jaw lift, increasing oxygen flow, mask ventilation, intubationpatients pre-oxygenation with pure oxygen at 30L/min for 1 minute, followed by sedation with slightly slow but steady breathing, disappearance of eyelash reflex, and continued oxygen flow at 30 L/min |
| HFNC50L/min | Experimental | Behavioral: jaw lift, increasing oxygen flow, mask ventilation, intubationpatients pre-oxygenation with pure oxygen at 30L/min for 1 minute, followed by sedation with slightly slow but steady breathing, adjustment of oxygen flow to 50L/min after disappearance of eyelash reflex. |
| HFNC70L/min | Experimental | Behavioral: jaw lift, increasing oxygen flow, mask ventilation, intubationpatients pre-oxygenation with pure oxygen at 30L/min for 1 minute, followed by sedation with slightly slow but steady breathing, adjustment of oxygen flow to 70L/min after disappearance of eyelash reflex. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing sedative gastrointestinal endoscopy
- Aged over 18.
- ASA classification I-III
- BMI>28kg/m2
- Compliance with ethics, patient willing to participate in the trial, signed informed consent form
Key exclusion criteria (7 listed)
- Contraindications for endoscopic procedures or patients refusing sedation/anesthesia.
- Patients with allergies to propofol, eggs, soybeans, or milk.
- Patients with gastrointestinal obstruction and gastric emptying disorders.
- Patients with acute pharyngitis, tonsillitis, and upper respiratory tract infections.
- 5: Patients with acute exacerbations of respiratory diseases such as asthma, bronchitis, and COPD. 6. Patients with acute arrhythmias and severe heart disease (congenital, valvular disease). 7. Patients requiring replacement therapy for severe liver or kidney dysfunction.
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 |
|---|---|---|
| jaw lift, increasing oxygen flow, mask ventilation, intubationWhen patients develop hypoxemia, the above interventions are sequentially employed to improve their oxygenation status. | Behavioural | HFNC30L/min, HFNC50L/min, HFNC70L/min |
Primary outcome
incidence of hypoxia
Time frame: 6 mintues before gastrointestinal completion
75% ≤ SpO2 < 90% for <60 second
6 secondary outcomes
incidences of subclinical respiratory depression and severe hypoxia
Time frame: 6 mintues before gastrointestinal completion
adverse event
Time frame: 6 mintues before gastrointestinal completion
airway obstruction
Time frame: 6 mintues before gastrointestinal completion
paradoxical response
Time frame: 6 mintues before gastrointestinal completion
airway intervention
Time frame: 6 mintues before gastrointestinal completion
waist circumfnrence, neck circumference
Time frame: before gastrointestinal
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 28 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Xiaoliang Wang study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing jaw lift, increasing oxygen flow, mask ventilation, intubation in people with Hypoxia and Obesity, run by XiaoLiang Wang 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 5 inclusion and 7 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 28 Aug 2026. 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?
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?
incidence of hypoxia (time frame: 6 mintues before gastrointestinal completion). 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 28 Aug 2026.