HypoxiaNCT06966934
Nasopharyngeal Airway Combined With Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Obesity Patients
A study testing NPA in people with Hypoxia and Obesity, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Gastroscopy is a commonly used, direct, and reliable method for screening and diagnosing digestive tract diseases. However, as an invasive examination, it can cause adverse reactions such as pain, nausea, vomiting, and choking cough in patients. 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?
- NPA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2025to 31 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing painless gastroscopy;
- Patients with an age greater than 18 years old;
- American Society of Anesthesiologists (ASA) physical status classification from Grade I to Grade III;
- Body Mass Index (BMI) greater than 28 kg/m²
Who cannot join
- Patients with contraindications to endoscopic procedures or those who refuse sedation/anesthesia;
- Patients allergic to propofol, eggs, soybeans, milk, etc.;
- Patients with gastrointestinal tract obstruction and gastric emptying disorders;
- Patients with acute pharyngitis, tonsillitis, and upper respiratory tract infections;
- Patients in the acute exacerbation stage of respiratory diseases such as asthma, bronchitis, and chronic obstructive pulmonary disease (COPD);
- Patients with acute arrhythmia and those with severe heart diseases (congenital diseases, valvular diseases);
Show all 11Show fewer
- Patients with severe hepatic and renal insufficiency who require alternative treatment;
- Patients with severe mental disorders who need medications to control their symptoms;
- Patients with moderate or above anemia, abnormal coagulation function, and hematological diseases;
- Patients with nasal cavity lesions leading to severe nasal congestion;
- Pregnant and lactating patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing
Tao Shan, MD, +8618852095135, 858727933@qq.com
About this study
Official title: The Application of Nasopharyngeal Airway Combined With Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Patients With Obesity
Gastroscopy is a commonly used, direct, and reliable method for screening and diagnosing digestive tract diseases. However, as an invasive examination, it can cause adverse reactions such as pain, nausea, vomiting, and choking cough in patients. Compared with ordinary gastroscopy, painless gastroscopy offers higher comfort and satisfaction for patients and greater convenience for endoscopists during operation.
The most common complication of painless gastroscopy diagnosis and treatment is hypoxia. High-flow nasal cannulala (HFNC) provides a higher oxygen concentration and flow rate than an ordinary nasal catheter. It has the functions of heating and humidifying, which can relieve the pressure on the nasal mucosa cilia, keep the airway unobstructed and moist, and reduce the risk of epistaxis. Due to changes in airway anatomical structures such as fat accumulation in the head and neck and hyperplasia of oropharyngeal soft tissues, obese patients are more prone to hypoxia during gastroscopy under sedation. Therefore, HFNC is often used to reduce the occurrence of hypoxia.
The nasopharyngeal airway (NPA) is used to maintain the patency of the upper respiratory tract and is suitable for patients with spontaneous breathing but partial obstruction of the upper respiratory tract. It is worth exploring how effective the combination of HFNC and NPA is in improving hypoxemia in obese patients during sedation.
Read the detailed description
Gastroscopy is a commonly used, direct, and reliable method for screening and diagnosing digestive tract diseases. However, as an invasive examination, it can cause adverse reactions such as pain, nausea, vomiting, and choking cough in patients. With the promotion of comfortable medical technology, more patients choose painless gastroscopy. Compared with ordinary gastroscopy, patients have a higher level of comfort and satisfaction, and it is more convenient for endoscopists to operate. Obesity is a chronic and multisystemic disease, and its prevalence is on the rise worldwide. It is estimated that by 2035, the prevalence of obesity will increase from 14% of the world's population to 24% in 2035. Due to the relationship between obesity and obesity-related comorbidities (such as dyslipidemia, hypertension, diabetes, cardiovascular diseases, and even certain types of cancer), it is necessary and important to actively control and treat obesity. Therefore, it is strongly recommended that such people undergo gastroscopy, whether it is for preoperative examination of bariatric surgery or for the diagnosis and treatment of gastrointestinal diseases. With the increase in the number of obese patients, the proportion of the patient group undergoing sedated gastrointestinal endoscopy has also increased. During painless gastroscopy, respiratory depression has always been one of the common adverse reactions. The incidence of hypoxia in obese patients during sedated gastroscopy is higher than that in patients with normal body weight, and it increases with the increase of the body mass index. Therefore, high-flow nasal cannulala (HFNC) is often used clinically to reduce the occurrence of hypoxia in obese patients during painless gastroscopy.
HFNC is a new type of ventilation method. It can provide patients with a high flow rate (20-70L/min) of oxygen through a special nasal cannula, and the oxygen concentration can be adjusted (21%-100%). It has the functions of heating and humidifying, which can relieve the pressure on the nasal mucosa cilia, keep the airway unobstructed and moist, and reduce the risk of epistaxis. In addition, HFNC can generate positive airway pressure (3-7cmH2O), increase the end-expiratory volume, help with alveolar re-expansion, prevent atelectasis, and reduce shunt. Obese patients have fat accumulation in the head and neck, hyperplasia of oropharyngeal soft tissues, reduced lung compliance, reduced lung volume and functional residual capacity. Some obese patients also suffer from obstructive sleep apnea, which increases the risk of hypoxemia in obese patients .
The Nasopharyngeal Airway (NPA) is a commonly used ventilation assistance tool. It is a soft and curved tube that is inserted through the nasal cavity so that the front end of the tube is located in the pharynx, bypassing the parts where obstruction may occur (such as the backward displacement of the tongue root, etc.), thus establishing a gas passage to allow air to smoothly pass through the upper respiratory tract into the trachea and lungs, ensuring the normal ventilation of patients. It is suitable for patients with spontaneous breathing but partial obstruction of the upper respiratory tract. For obese patients, NPA has significant advantages in reducing airway obstruction, being easy to insert, having good tolerance, not affecting oral cavity operations, reducing respiratory resistance, and reducing complications. It is an effective tool for managing the airway of obese patients. Therefore, the investigators propose the hypothesis that the use of NPA combined with HFNC during painless gastroscopy in obese patients can further reduce the incidence of hypoxia in obese patients.
- Conditions
- Hypoxia, Obesity, Gastrostomy
- Being tested
- NPA
- Keywords
- Obese patients, sedative gastroscopy, high-flow nasal oxygen therapy
- Medical subject headings
- Hypoxia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPADevice
After sedation, the nasopharyngeal airway (NPA) is inserted when the patient's breathing becomes slightly slow but stable and the eyelash reflex disappears.
| Study group | Role | What they receive |
|---|---|---|
| HFNC30L/min | No intervention | The patient receives pre-oxygenation with pure oxygen at 30 L/min for 1 minute. After sedation, when the patient's breathing becomes slightly slower but stable and the eyelash reflex disappears, continue to supply oxygen at a flow rate of 30 L/min |
| HFNC30L/min AND NPA | Experimental | The patient receives pre-oxygenation with pure oxygen at 30 L/min for 1 minute. After sedation, the nasopharyngeal airway (NPA) is inserted when the patient's breathing becomes slightly slow but stable and the eyelash reflex disappears Receives: Device: NPA |
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 s
Measured: 6 mintues after gastroscopy completion
Secondary outcomes (6)
incidence of subclinical respiratory depression
90% ≤ SpO2 < 95%
Measured: 6 mintues after gastroscopy completion
incidence of severe hypoxia
SpO2 < 75% for any duration or 75% ≤ SpO2 < 90% for ≥60 s
Measured: 6 mintues after gastroscopy completion
periprocedural complications
vomit and nausea
Measured: 6 mintues after gastroscopy completion
airway associated complications
incidence of patients with glossoptosis, excessive oropharynx secretion, laryngeal spasm,bronchospam
Measured: 6 mintues after gastroscopy completion
adverse event
patients dispalyed unpredicatable movement, overexcitement and delirium after sedation with propofol
Measured: 6 mintues after gastroscopy completion
airway intervention to handle hypoxia
jaw lift,increase the flow of oxygen, Mask ventilation,Intubation
Measured: 6 mintues after gastroscopy completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start14 May 2025
- Primary completion15 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
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.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lihai Chen, Doctor, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966934
- Sponsor's protocol ID
- KY20250327-10
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2025
- Last updated
- 22 Jul 2025
- 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 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Nasopharyngeal Airway Combined With Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Patients With Obesity
- ClinicalTrials.gov ID
- NCT06966934
- Acronym / sponsor ID
- KY20250327-10
- Conditions
- Hypoxia, Obesity, Gastrostomy
- Keywords
- Obese patients, sedative gastroscopy, high-flow nasal oxygen therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 13 May 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.
Gastroscopy is a commonly used, direct, and reliable method for screening and diagnosing digestive tract diseases. However, as an invasive examination, it can cause adverse reactions such as pain, nausea, vomiting, and choking cough in patients. Compared with ordinary gastroscopy, painless gastroscopy offers higher comfort and satisfaction for patients and greater convenience for endoscopists during operation.
The most common complication of painless gastroscopy diagnosis and treatment is hypoxia. High-flow nasal cannulala (HFNC) provides a higher oxygen concentration and flow rate than an ordinary nasal catheter. It has the functions of heating and humidifying, which can relieve the pressure on the nasal mucosa cilia, keep the airway unobstructed and moist, and reduce the risk of epistaxis. Due to changes in airway anatomical structures such as fat accumulation in the head and neck and hyperplasia of oropharyngeal soft tissues, obese patients are more prone to hypoxia during gastroscopy under sedation. Therefore, HFNC is often used to reduce the occurrence of hypoxia.
The nasopharyngeal airway (NPA) is used to maintain the patency of the upper respiratory tract and is suitable for patients with spontaneous breathing but partial obstruction of the upper respiratory tract. It is worth exploring how effective the combination of HFNC and NPA is in improving hypoxemia in obese patients during sedation.
Detailed description
Gastroscopy is a commonly used, direct, and reliable method for screening and diagnosing digestive tract diseases. However, as an invasive examination, it can cause adverse reactions such as pain, nausea, vomiting, and choking cough in patients. With the promotion of comfortable medical technology, more patients choose painless gastroscopy. Compared with ordinary gastroscopy, patients have a higher level of comfort and satisfaction, and it is more convenient for endoscopists to operate. Obesity is a chronic and multisystemic disease, and its prevalence is on the rise worldwide. It is estimated that by 2035, the prevalence of obesity will increase from 14% of the world's population to 24% in 2035. Due to the relationship between obesity and obesity-related comorbidities (such as dyslipidemia, hypertension, diabetes, cardiovascular diseases, and even certain types of cancer), it is necessary and important to actively control and treat obesity. Therefore, it is strongly recommended that such people undergo gastroscopy, whether it is for preoperative examination of bariatric surgery or for the diagnosis and treatment of gastrointestinal diseases. With the increase in the number of obese patients, the proportion of the patient group undergoing sedated gastrointestinal endoscopy has also increased. During painless gastroscopy, respiratory depression has always been one of the common adverse reactions. The incidence of hypoxia in obese patients during sedated gastroscopy is higher than that in patients with normal body weight, and it increases with the increase of the body mass index. Therefore, high-flow nasal cannulala (HFNC) is often used clinically to reduce the occurrence of hypoxia in obese patients during painless gastroscopy.
HFNC is a new type of ventilation method. It can provide patients with a high flow rate (20-70L/min) of oxygen through a special nasal cannula, and the oxygen concentration can be adjusted (21%-100%). It has the functions of heating and humidifying, which can relieve the pressure on the nasal mucosa cilia, keep the airway unobstructed and moist, and reduce the risk of epistaxis. In addition, HFNC can generate positive airway pressure (3-7cmH2O), increase the end-expiratory volume, help with alveolar re-expansion, prevent atelectasis, and reduce shunt. Obese patients have fat accumulation in the head and neck, hyperplasia of oropharyngeal soft tissues, reduced lung compliance, reduced lung volume and functional residual capacity. Some obese patients also suffer from obstructive sleep apnea, which increases the risk of hypoxemia in obese patients .
The Nasopharyngeal Airway (NPA) is a commonly used ventilation assistance tool. It is a soft and curved tube that is inserted through the nasal cavity so that the front end of the tube is located in the pharynx, bypassing the parts where obstruction may occur (such as the backward displacement of the tongue root, etc.), thus establishing a gas passage to allow air to smoothly pass through the upper respiratory tract into the trachea and lungs, ensuring the normal ventilation of patients. It is suitable for patients with spontaneous breathing but partial obstruction of the upper respiratory tract. For obese patients, NPA has significant advantages in reducing airway obstruction, being easy to insert, having good tolerance, not affecting oral cavity operations, reducing respiratory resistance, and reducing complications. It is an effective tool for managing the airway of obese patients. Therefore, the investigators propose the hypothesis that the use of NPA combined with HFNC during painless gastroscopy in obese patients can further reduce the incidence of hypoxia in obese patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC30L/min | No intervention | –The patient receives pre-oxygenation with pure oxygen at 30 L/min for 1 minute. After sedation, when the patient's breathing becomes slightly slower but stable and the eyelash reflex disappears, continue to supply oxygen at a flow rate of 30 L/min |
| HFNC30L/min AND NPA | Experimental | Device: NPAThe patient receives pre-oxygenation with pure oxygen at 30 L/min for 1 minute. After sedation, the nasopharyngeal airway (NPA) is inserted when the patient's breathing becomes slightly slow but stable and the eyelash reflex disappears |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing painless gastroscopy;
- Patients with an age greater than 18 years old;
- American Society of Anesthesiologists (ASA) physical status classification from Grade I to Grade III;
- Body Mass Index (BMI) greater than 28 kg/m²
Key exclusion criteria (11 listed)
- Patients with contraindications to endoscopic procedures or those who refuse sedation/anesthesia;
- Patients allergic to propofol, eggs, soybeans, milk, etc.;
- Patients with gastrointestinal tract obstruction and gastric emptying disorders;
- Patients with acute pharyngitis, tonsillitis, and upper respiratory tract infections;
- Patients in the acute exacerbation stage of respiratory diseases such as asthma, bronchitis, and chronic obstructive pulmonary disease (COPD);
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 |
|---|---|---|
| NPAAfter sedation, the nasopharyngeal airway (NPA) is inserted when the patient's breathing becomes slightly slow but stable and the eyelash reflex disappears. | Device | HFNC30L/min AND NPA |
Primary outcome
incidence of hypoxia
Time frame: 6 mintues after gastroscopy completion
75% ≤ SpO2 < 90% for <60 s
6 secondary outcomes
incidence of subclinical respiratory depression
Time frame: 6 mintues after gastroscopy completion
incidence of severe hypoxia
Time frame: 6 mintues after gastroscopy completion
periprocedural complications
Time frame: 6 mintues after gastroscopy completion
airway associated complications
Time frame: 6 mintues after gastroscopy completion
adverse event
Time frame: 6 mintues after gastroscopy completion
airway intervention to handle hypoxia
Time frame: 6 mintues after gastroscopy completion
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 22 Jul 2025.
- 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.
Lihai Chen, Doctor 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 NPA in people with Hypoxia and Obesity, run by Nanjing First Hospital, Nanjing Medical University 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 4 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 22 Jul 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 Jing Hu, Master (15366110201, hujingmz@163.com), 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: 6 mintues after gastroscopy 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 22 Jul 2025.