ClinicalTrials.Veeva

Menu

Nasal Mask Kit in Gastrointestinal Endoscopy (NASO)

Shanghai Jiao Tong University logo

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)

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

Trial contacts and locations

3

Loading...

Central trial contact

Xiangyang Cheng, B.S.; Diansan Su, Dr.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems