NCT06585306 High-flow Nasal Oxygen Therapy in Obese Patients Undergoing Sedative Gastroscopy
| NCT ID | NCT06585306 |
| Status | Recruiting |
| Phase | — |
| Sponsor | XiaoLiang Wang |
| Condition | Hypoxia |
| Study Type | INTERVENTIONAL |
| Enrollment | 864 participants |
| Start Date | 2024-10-23 |
| Primary Completion | 2025-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 864 participants in total. It began in 2024-10-23 with a primary completion date of 2025-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. Patients undergoing sedative gastroscopy 2. Aged over 18. 3. ASA classification I-III 4. Interincisal distance \>6.5cm, no micrognathia, limited mouth opening and limited cervical spine movement 5. Compliance with ethics, patient willing to participate in the trial, signed informed consent form Exclusion Criteria: 1. Contraindications for endoscopic procedures or patients refusing sedation/anesthesia. 2. Patients with allergies to propofol, eggs, soybeans, or milk. 3. Patients with gastrointestinal obstruction and gastric emptying disorders. 4. 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.
Contact & Investigator
Xiaoliang Wang
STUDY DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT06585306 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypoxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06585306 currently recruiting?
Yes, NCT06585306 is actively recruiting participants. Contact the research team at hujingmz@163.com for enrollment information.
Where is the NCT06585306 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06585306 clinical trial?
NCT06585306 is sponsored by XiaoLiang Wang. The principal investigator is Xiaoliang Wang at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 864 participants.