Nasal Mask Kit in Gastrointestinal Endoscopy (NASO)

Shanghai Jiao Tong University

Status: Enrolling

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

Treatments: Device: nasal mask oxygen kit; Device: regular nasal cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT05405530

RenJiH-2022-01-04

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

nasal mask oxygen group

Experimental group

Description:

In this group, patients use the nasal mask oxygen kit for oxygenation.

Treatment:

Device: nasal mask oxygen kit

regular nasal cannula group

Active Comparator group

Description:

In this group, patients use the regular nasal cannula for oxygenation.

Treatment:

Device: regular nasal cannula