Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients

Last updated: March 17, 2024
Sponsor: RenJi Hospital
Overall Status: Completed

Phase

N/A

Condition

Colon Cancer

Esophageal Cancer

Gastric Cancer

Treatment

Standard monitoring

Capnography monitoring

Clinical Study ID

NCT05030870
RenjiH-20201201
  • Ages 65-79
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol and sufentanil, especially in elderly people. The aim of this randomized study was to determine whether intervention based on additional capnographic monitoring reduces the incidence of hypoxia in gastrointestinal endoscopes procedures for elderly patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 65 ≤ Age <80
  • patients undergoing gastrointestinal endoscopes
  • patients signed informed consent form
  • ASA classification I-II

Exclusion

Exclusion Criteria:

  • Coagulation disorders or a tendency of nose bleeding
  • An episode/exacerbation of congestive heart failure (CHF) that requires a change inmedication, diet or hospitalization from any cause in the last 6 months
  • Severe aortic stenosis or mitral stenosis
  • Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG),valve replacement surgery) in the last 6 months
  • Acute myocardial infarction in the last 6 months
  • Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid ofhemodynamics instability
  • Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lungdisease requiring supplemental chronic or intermittent oxygen therapy)
  • Pre-existing bradycardia (heart rate < 50 / min), or hypoxia (SaO2< 90 % )
  • Need supplemental oxygen because of pre-existing diseases
  • Emergency procedure or surgery
  • Multiple trauma
  • Upper respiratory tract infection
  • Allergy to propofol or tape and adhesives

Study Design

Total Participants: 1800
Treatment Group(s): 2
Primary Treatment: Standard monitoring
Phase:
Study Start date:
September 01, 2021
Estimated Completion Date:
January 01, 2023

Connect with a study center

  • Henan Provincial People's Hospital

    Zhenzhou, Henan 450003
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Qingdao, Shandong 250012
    China

    Site Not Available

  • Renji Hospital

    Shanghai, Shanghai 200127
    China

    Site Not Available

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