CapnoGI: Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients

Sponsor

RenJi Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05030870

Collaborator

Henan Provincial People's Hospital (Other), Qilu Hospital of Shandong University (Other)

1,800

Enrollment

Locations

Arms

Anticipated Duration (Months)

600

Patients Per Site

22.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxia Gastric Cancer Gastric Polyp Colon Polyp Colon Cancer Esophageal Cancer	Device: Capnography monitoring Device: Standard monitoring	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Capnography monitoring Standard monitoring and capnographic monitoring. Device: Standard monitoring Standard monitoring but no capnographic monitoring
Active Comparator: 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.	Device: Standard monitoring Standard monitoring but no capnographic monitoring

Arm

Intervention/Treatment

Experimental: 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.

Device: Capnography monitoring

Standard monitoring and capnographic monitoring.

Device: Standard monitoring

Standard monitoring but no capnographic monitoring

Active Comparator: 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.

Device: Standard monitoring

Standard monitoring but no capnographic monitoring

Outcome Measures

Primary Outcome Measures

The incidence of hypoxia [Patients will be followed for the duration of hospital stay, an expected average of 2 hours]
(75% ≤ SpO2 < 90% for <60 s)

Secondary Outcome Measures

The incidence of sub-clinical respiratory depression [Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
(90% ≤ SpO2 < 95%)
The incidence of severe hypoxia [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)
The incidence of capnography curve decreased by half or more than the baseline and even disappeared without hypoxia [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%
The incidence of other adverse events [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henan Provincial People's Hospital	Zhenzhou	Henan	China	450003
2	Qilu Hospital of Shandong University	Qingdao	Shandong	China	250012
3	Renji Hospital	Shanghai	Shanghai	China	200127