NCT06710613

Brief Summary

During painless gastroscopy, the occurrence of hypoxia is a critical concern, especially under intravenous anesthesia using propofol. This study aimed to investigate the incidence of hypoxia during painless gastroscopy and evaluate preventive measures.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

November 23, 2024

Last Update Submit

December 11, 2024

Conditions

Hypoxia

Keywords

High flow nasal cannula oxygen

Outcome Measures

Primary Outcomes (1)

  • incidence of hypoxia

    SpO2 levels less than 90%

    60 seconds

Secondary Outcomes (1)

  • the incidence of subclinical respiratory depression and adverse events

    30 minute

Study Arms (2)

control group

conventional nasal cannula oxygen group

experimental group

high flow nasal cannula oxygen group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who underwent painless gastroscopy

You may qualify if:

  • Patients aged 18 to 70
  • Undergoing painless gastroscopy under intravenous anesthesia

You may not qualify if:

  • Severe respiratory disease
  • History of nasal bleeding or mucosal injury
  • Emergency cases
  • Pregnant or lactating female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanchang University

Nanchang, Jiangxi, 330000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Medical record

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fengli Liu, master

    Nanchang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

November 23, 2024

First Posted

November 29, 2024

Study Start

November 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)