Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients

NCT ID: NCT05030870

Last Updated: 2024-03-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypoxia Gastric Cancer Gastric Polyp Colon Polyp Colon Cancer Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

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.

Group Type EXPERIMENTAL

Capnography monitoring

Intervention Type DEVICE

Standard monitoring and capnographic monitoring.

Standard monitoring

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Standard monitoring

Intervention Type DEVICE

Standard monitoring but no capnographic monitoring

Interventions

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Capnography monitoring

Standard monitoring and capnographic monitoring.

Intervention Type DEVICE

Standard monitoring

Standard monitoring but no capnographic monitoring

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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diansan su

Vice Chair of the Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Qilu Hospital of Shandong University

Qingdao, Shandong, China

Site Status

Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

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.

Reference Type DERIVED
PMID: 36918924 (View on PubMed)

Other Identifiers

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RenjiH-20201201

Identifier Type: -

Identifier Source: org_study_id

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