Nasal Mask Kit in Gastrointestinal Endoscopy (NASO)

June 2, 2025 updated by: diansan su, RenJi Hospital

Nasal Mask Oxygen Reduces the Incidence of Hypoxia Undergoing Gastrointestinal Endoscopy Under Propofol Sedation: a Multicenter Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Provincial People's Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • RenJi Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • First Affiliated Hospital of Kunming Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nasal mask oxygen group
In this group, patients use the nasal mask oxygen kit for oxygenation.
Device: nasal mask oxygen kit
Using the nasal mask oxygen kit for oxygenation.
Active Comparator: regular nasal cannula group
In this group, patients use the regular nasal cannula for oxygenation.
Device: regular nasal cannula
Using nasal cannula for oxygenation.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of sub-clinical respiratory depression
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
(90% ≤ SpO2 < 95%)
Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
The incidence of severe hypoxia
Time Frame: 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)
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of other adverse events
Time Frame: 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
Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Henan Provincial People's Hospital
First Affiliated Hospital of Kunming Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

June 6, 2023

Study Completion (Actual)

June 6, 2023

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 6, 2022

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

June 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RenJiH-2022-01-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Beginning 3months and ending 5 years following article publication.

IPD Sharing Access Criteria

The data will be available to other researchers upon request, with information shared after approval by the corresponding author (D-SS).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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