Actively Recruiting
Application of Nasopharyngeal Airway Combined with Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Obese Patients
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-07-22
364
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a nasopharyngeal airway (NPA) combined with nasal high-flow oxygen therapy (HFNC) during painless gastroscopy in patients with obesity. Gastroscopy is a common method to screen and diagnose digestive tract diseases but can cause discomfort and adverse reactions. Obese patients face a higher risk of hypoxia during sedation due to changes in airway anatomy and respiratory function, so this study aims to see if combining NPA with HFNC can reduce hypoxia incidents in this group. The study compares two approaches during painless gastroscopy for obese patients. One group receives high-flow nasal cannula oxygen at 30 L/min after sedation, while the other group receives the same oxygen flow plus the insertion of an NPA to keep the airway open. Both groups start with pre-oxygenation using pure oxygen at 30 L/min for one minute before sedation. The trial involves random assignment to these groups and single masking during the procedure. Participants will be monitored for hypoxia and other respiratory complications during and after the gastroscopy, with evaluations occurring 6 minutes post-procedure. Assessments include the incidence of hypoxia, subclinical respiratory depression, severe hypoxia, airway complications, adverse events, and airway interventions needed. The study also tracks patient comfort and safety. The total participation time includes the gastroscopy and immediate post-procedure monitoring, aiming to improve respiratory management in obese patients undergoing painless gastroscopy.
CONDITIONS
Brief Title
Nasopharyngeal Airway Combined With Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Obesity Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing painless gastroscopy
- Age greater than 18 years old
- ASA physical status classification Grade I to Grade III
- Body Mass Index (BMI) greater than 28 kg/m²
You will not qualify if you...
- Contraindications to endoscopic procedures or refusal of sedation/anesthesia
- Allergy to propofol, eggs, soybeans, or milk
- Gastrointestinal tract obstruction or gastric emptying disorders
- Acute pharyngitis, tonsillitis, or upper respiratory tract infections
- Acute exacerbation of asthma, bronchitis, or COPD
- Acute arrhythmia or severe heart diseases including congenital and valvular diseases
- Severe liver or kidney failure requiring other treatments
- Severe mental disorders needing medication control
- Moderate or severe anemia, abnormal blood clotting, or blood diseases
- Nasal cavity lesions causing severe congestion
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo painless gastroscopy with oxygen therapy using either nasal high-flow oxygen alone or combined with a nasopharyngeal airway to reduce hypoxia risk during the procedure.
1 procedure visit (in-person)
Duration - Approximately 6 minutes after gastroscopy completion
Participants are monitored for adverse events and respiratory outcomes immediately after the gastroscopy procedure.
1 follow-up observation visit (in-person)
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, China
Actively Recruiting
Research Team
J
Jing Hu, Master
T
Tao Shan, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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