Skip to main content
OpenTrials
Completed

NCT Number: NCT05030870

Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypoxia Colon Cancer Colon Polyp Colonic Diseases Colonic Neoplasms Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastric Polyp Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyposis, Gastric Polyps Signs and Symptoms Signs and Symptoms, Respiratory Stomach Diseases Stomach Neoplasms

Age range

65 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henan Provincial People's Hospital, Zhenzhou, Henan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Coagulation disorders or a tendency of nose bleeding
  • An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, 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 of hemodynamics instability
  • Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease 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

Treatment and study plan

Capnography monitoring

Device

Standard monitoring and capnographic monitoring.

Standard monitoring

Device

Standard monitoring but no capnographic monitoring

Primary outcomes

  1. The incidence of hypoxia

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

    (75% ≤ SpO2 < 90% for <60 s)

Secondary outcomes

  1. 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%)

  2. 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)

  3. The incidence of capnography curve decreased by half or more than the baseline and even disappeared without hypoxia

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

    capnography curve decreased by half or more than the baseline and even disappeared, SpO2 >90%

  4. 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

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • Henan Provincial People's Hospital
  • Qilu Hospital of Shandong University

Registry information

Official study title

Capnographic Monitoring Decrease the Incidence of Hypoxia of the Elderly Patients Undergoing Gastrointestinal Endoscopy Procedure: a Randomized Multicenter Clinical Trial

Acronym: CapnoGI

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 1, 2021
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.