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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05030870
Other study ID # RenjiH-20201201
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date January 1, 2023

Study information

Verified date March 2024
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1800
Est. completion date January 1, 2023
Est. primary completion date September 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 79 Years
Eligibility 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

Study Design


Intervention

Device:
Capnography monitoring
Standard monitoring and capnographic monitoring.
Standard monitoring
Standard monitoring but no capnographic monitoring

Locations

Country Name City State
China Qilu Hospital of Shandong University Qingdao Shandong
China Renji Hospital Shanghai Shanghai
China Henan Provincial People's Hospital Zhenzhou Henan

Sponsors (3)

Lead Sponsor Collaborator
RenJi Hospital Henan Provincial People's Hospital, Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of hypoxia (75% = SpO2 < 90% for <60 s) Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary The incidence of sub-clinical respiratory depression (90% = SpO2 < 95%) Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Secondary The incidence of severe hypoxia (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
Secondary The incidence of capnography curve decreased by half or more than the baseline and even disappeared without hypoxia capnography curve decreased by half or more than the baseline and even disappeared, SpO2 >90% Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Secondary The incidence of other adverse events 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
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