Nasal Mask Kit in Gastrointestinal Endoscopy

Not Applicable

Completed

• Conditions: Gastric Polyp; Colon Polyp; Hypoxia; Gastric Cancer; Colon Cancer; Esophageal Cancer

• Registration Number: NCT05405530
• Lead Sponsor: RenJi Hospital

Brief Summary

Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol. The nasal mask oxygen kit has good sealing to ensure an adequate oxygen supply and is convenient and economical.The aim of this randomized study was to determine whether the nasal mask oxygen kit reduces the incidence of hypoxia in gastrointestinal endoscopes procedures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Study Start: 2022-09-01
• Primary Completion: 2023-06-06
• Study Completion: 2023-06-06
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1204

Inclusion Criteria

• 18≤ Age ≤60
• patients undergoing combined gastroendoscopy and colonoscopy procedure
• patients signed informed consent form
• ASA classification I-II
• Estimated procedure time <=45min

Exclusion Criteria

• Coagulation disorders or a tendency of nose bleeding
• Diagnosed heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.)
• Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy)
• hypoxia (SpO2< 90 % )
• Upper respiratory tract infection
• increased intracranial pressure
• Fever (core body temperature >37.5 ℃)
• Pregnancy, breastfeeding, or positive pregnancy test
• Emergency procedure or surgery
• Multiple trauma
• Allergy to propofol or tape and adhesives
• BMI<18.5 or BMI>30

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of hypoxia	Patients will be followed for the duration of hospital stay, an expected average about 2 hours]	(75% ≤ SpO2 \< 90% for \<60 s)

Secondary Outcome Measures

Name	Time	Method
The incidence of severe hypoxia	Patients will be followed for the duration of hospital stay, an expected average about 2 hours	(SpO2 \< 75% or 75% ≤ SpO2 \< 90% for \>/=60 s)
The incidence of other adverse events	Patients will be followed for the duration of hospital stay, an expected average about 2 hours]	Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
The incidence of sub-clinical respiratory depression	Patients will be followed for the duration of hospital stay, an expected average about 2 hours]	(90% ≤ SpO2 \< 95%)

Trial Locations

Locations (3)

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China

First Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, Yunnan, China