Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients
NCT ID: NCT05030870
Last Updated: 2024-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1800 participants
INTERVENTIONAL
2021-09-01
2023-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Capnographic monitoring group
In this group, in addition to the standard monitoring including observation, pulse oxygen saturation, non-invasive blood pressure, electrocardiogram in selected patients, the capnographic is also monitored. The capnographic data of the patients are available for additional noninvasive assessment of ventilation.
Capnography monitoring
Standard monitoring and capnographic monitoring.
Standard monitoring
Standard monitoring but no capnographic monitoring
Standard monitoring group
In this group, standard monitoring including observation, pulse oxygen saturation, non-invasive blood pressure, electrocardiogram in selected patients. Capnographic data are not visible by closing the CO2 sampling line till the endoscopy end.
Standard monitoring
Standard monitoring but no capnographic monitoring
Interventions
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Capnography monitoring
Standard monitoring and capnographic monitoring.
Standard monitoring
Standard monitoring but no capnographic monitoring
Eligibility Criteria
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Inclusion Criteria
* patients undergoing gastrointestinal endoscopes
* patients signed informed consent form
* ASA classification I-II
Exclusion Criteria
* 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
65 Years
79 Years
ALL
Yes
Sponsors
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Henan Provincial People's Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
RenJi Hospital
OTHER
Responsible Party
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diansan su
Vice Chair of the Department of Anesthesiology
Principal Investigators
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Diansan Su, Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology Renji Hospital
Locations
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Henan Provincial People's Hospital
Zhenzhou, Henan, China
Qilu Hospital of Shandong University
Qingdao, Shandong, China
Renji Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Lian Q, Chen S, Cheng X, Zhang J, Yu W, Zhou R, Su D. Capnographic monitoring reduces hypoxia incidence in older patients undergoing gastrointestinal endoscopy under propofol sedation: study protocol for a multicenter randomized controlled trial. Trials. 2023 Mar 15;24(1):192. doi: 10.1186/s13063-023-07208-0.
Other Identifiers
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RenjiH-20201201
Identifier Type: -
Identifier Source: org_study_id
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