NCT06705894

Brief Summary

The purpose of this study is to investigate the incidence of respiratory complications after gastroenteroscopy, and establish a Logistic regression model to analyze the related risk factors of respiratory complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,313

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

November 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

January 2, 2026

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

November 23, 2024

Last Update Submit

December 28, 2025

Conditions

Pneumonia, Aspiration

Keywords

Gastrointestinal endoscopyRespiratory complicationsSedation

Outcome Measures

Primary Outcomes (3)

  • Postoperative cough

    The investigator needs to use NRS scores to evaluate the severity of the cough, if patients develop a new cough after surgery.The score from 0 (no) to 10 (extremely serious).Duration and treatment are also required to be recorded.

    24 hours after surgery

  • Postoperative fever

    The investigator needs to record the patient's maximum body temperature. Duration and treatment are also required to be recorded.

    24 hours after surgery

  • Short of breath

    The investigator needs to use mMRC questionnaire to evaluate the severity of SOB.Duration and treatment are also required to be recorded.

    24 hours after surgery

Secondary Outcomes (1)

  • Adverse events during surgery

    During surgery

Study Arms (2)

M group

Gratrointestinal endoscopy is undergone with moderate sedation.

D/G group

Gratrointestinal endoscopy is undergone without deep sedation/general anesthsia.

Eligibility Criteria

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

Population undergoing gastrointestinal endoscopy examination at Qingdao University Affiliated Hospital from December 2024 to February 2025.

You may qualify if:

  • Age ≥18 years old;
  • Qualified gastrointestinal tract preparation in strict accordance with the preparation requirements related to gastroenteroscopy;

You may not qualify if:

  • Patients with respiratory system symptoms or history before surgery;
  • Patients in need of a tracheal intubation;
  • Refuse follow-up;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shangdong, 266000, China

Location

MeSH Terms

Conditions

Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 23, 2024

First Posted

November 26, 2024

Study Start

December 1, 2024

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

January 2, 2026

Record last verified: 2025-04

Locations

CN(1)