Actively Recruiting
Randomized Controlled Study of Hypoxia Incidence Using a New Oropharyngeal Airway During Painless Gastroenteroscopy
Led by Qianfoshan Hospital · Updated on 2024-08-27
228
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new oropharyngeal airway device designed to improve airway management during painless gastroenteroscopy. The study aims to determine if this device can reduce airway obstruction and hypoxia incidents, especially in obese and elderly patients who are more vulnerable to oxygen drops during anesthesia. This randomized, double-blind trial investigates the safety and effectiveness of this new airway compared to traditional nasal oxygen delivery methods. Participants are divided into two groups. Both groups receive oxygen at 5-6 liters per minute for about one minute before anesthesia induction, with sedatives propofol and sufentanil administered. The experimental group uses the new oropharyngeal airway connected to the endoscopic bite to deliver oxygen and monitor carbon dioxide levels, while the control group uses a nasal catheter. Propofol is continuously infused to maintain anesthesia until the procedure ends. Throughout the procedure, researchers observe the incidence of hypoxia and severe hypoxia, coughing, laryngeal spasm, and other adverse events. They also record drug dosages and endoscopist satisfaction. Monitoring includes oxygen saturation and carbon dioxide levels. The total participation includes anesthesia, endoscopy, and 30 minutes post-procedure for satisfaction assessment. The study will provide clinical experience and reference for anesthesia care in obese patients undergoing painless gastroenteroscopy.
CONDITIONS
Brief Title
Application of New Oropharyngeal Airway Management in Patients Undergoing Painless Gastroenteroscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary acceptance to participate
- ASA physical status level 1 or 2
- Age between 18 and 95 years
- Mallampati grade I or II
You will not qualify if you...
- Blood clotting disorders or tendency to oropharyngeal bleeding, mucosal damage, space occupation, or difficulty placing oropharyngeal airway
- Severe cardiac insufficiency (less than 4 METs)
- Severe renal insufficiency requiring dialysis before surgery
- Diagnosed severe liver insufficiency
- Diagnosed chronic obstructive pulmonary disease or other acute/chronic lung diseases requiring oxygen therapy
- Increased intracranial pressure
- Upper respiratory tract infections such as mouth, nose, or throat infections
- Fever with core body temperature above 37.5°C
- Confirmed pregnancy or breastfeeding
- Allergy to sedatives like propofol or equipment such as tape
- Emergency surgery
- Multiple trauma
- Preoperative oxygen saturation less than 95% on room air
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the gastroenteroscopy procedure (typically short, within a single day)
Participants undergo painless gastroenteroscopy under anesthesia using either the new oropharyngeal airway device or a traditional oral cushion set, with oxygen supplied and anesthesia maintained until the examination is complete.
1 visit (in-person)
Duration - Up to 30 minutes after surgery
Participants are monitored for safety and recovery after the procedure, including assessment of adverse events and endoscopist satisfaction.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Shandong First Medical University（Qianfoshan Hospital, Shandong Province）
Jinan, China
Actively Recruiting
Research Team
J
Jianbo Wu
Q
qi You
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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