NCT05405530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

June 1, 2022

Last Update Submit

June 2, 2025

Conditions

HypoxiaGastric CancerGastric PolypColon PolypColon CancerEsophageal Cancer

Keywords

nasal maskHypoxiaGastrointestinal endoscopyPropofolCapnographic Monitoring

Outcome Measures

Primary Outcomes (1)

  • The incidence of hypoxia

    (75% ≤ SpO2 \< 90% for \<60 s)

    Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

Secondary Outcomes (3)

  • The incidence of sub-clinical respiratory depression

    Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

  • The incidence of severe hypoxia

    Patients will be followed for the duration of hospital stay, an expected average about 2 hours

  • The incidence of other adverse events

    Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

Study Arms (2)

nasal mask oxygen group

EXPERIMENTAL

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

Device: nasal mask oxygen kit

regular nasal cannula group

ACTIVE COMPARATOR

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

Device: regular nasal cannula

Interventions

nasal mask oxygen kitDEVICE

Using the nasal mask oxygen kit for oxygenation.

nasal mask oxygen group
regular nasal cannulaDEVICE

Using nasal cannula for oxygenation.

regular nasal cannula group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

Related Publications (1)

  • Cheng X, Zhang X, Zhang J, Hu Z, Zhang J, Lian Q, Ding X, He Y, Shi M, Zhang Y, Tian M, Zheng H, Li Z, Wang Y, Yu W, Shao J, Su D. Efficacy of a nasal mask oxygen kit versus regular nasal cannula in sedated gastrointestinal endoscopy: a multicentre, randomised clinical trial. BMJ Open Gastroenterol. 2025 Jul 7;12(1):e001834. doi: 10.1136/bmjgast-2025-001834.

    PMID: 40623715DERIVED

MeSH Terms

Conditions

HypoxiaStomach NeoplasmsPolyposis, GastricColonic PolypsColonic NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesIntestinal PolypsPolypsPathological Conditions, AnatomicalColorectal NeoplasmsIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesHead and Neck NeoplasmsEsophageal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chair of the Department of Anesthesiology

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 6, 2022

Study Start

September 1, 2022

Primary Completion

June 6, 2023

Study Completion

June 6, 2023

Last Updated

June 5, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Beginning 3months and ending 5 years following article publication.
Access Criteria
The data will be available to other researchers upon request, with information shared after approval by the corresponding author (D-SS).

Locations

CN(3)