Nasopharyngeal Airway Combined With Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Obesity Patients

NCT06966934 | Recruiting DMC

• 1 other identifier: KY20250327-10
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypoxia; Obesity; Gastrostomy

Keywords

Obese patients; sedative gastroscopy; high-flow nasal oxygen therapy

Outcome Measures

Primary Outcomes (1)

• incidence of hypoxia

  75% ≤ SpO2 \< 90% for \<60 s

  6 mintues after gastroscopy completion

Secondary Outcomes (6)

• incidence of subclinical respiratory depression

  6 mintues after gastroscopy completion

• incidence of severe hypoxia

  6 mintues after gastroscopy completion

• periprocedural complications

  6 mintues after gastroscopy completion

• airway associated complications

  6 mintues after gastroscopy completion

• adverse event

  6 mintues after gastroscopy completion

Study Arms (2)

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

Device: NPA

Interventions

NPA DEVICE

After sedation, the nasopharyngeal airway (NPA) is inserted when the patient's breathing becomes slightly slow but stable and the eyelash reflex disappears.

HFNC30L/min AND NPA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Hypoxia; Obesity

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Lihai Chen, Doctor

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Jing Hu, Master

CONTACT

15366110201; hujingmz@163.com

Tao Shan, Master

CONTACT

18852095135; 858727933@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 13, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)