Back to resultsCapnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients (CapnoGI)
Primary Purpose
Hypoxia, Gastric Cancer, Gastric Polyp
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Capnography monitoring
Standard monitoring
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxia focused on measuring Capnographic Monitoring, Hypoxia, Gastrointestinal endoscopy, Elderly patients, Propofol
Eligibility Criteria
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
Sites / Locations
- Henan Provincial People's HospitalRecruiting
- Qilu Hospital of Shandong UniversityRecruiting
- Renji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Capnographic monitoring group
Standard monitoring group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The incidence of hypoxia
(75% ≤ SpO2 < 90% for <60 s)
Secondary Outcome Measures
The incidence of sub-clinical respiratory depression
(90% ≤ SpO2 < 95%)
The incidence of severe hypoxia
(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
capnography curve decreased by half or more than the baseline and even disappeared, SpO2 >90%
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Full Information
NCT ID
NCT05030870
First Posted
August 20, 2021
Last Updated
March 7, 2022
Sponsor
RenJi Hospital
Collaborators
Henan Provincial People's Hospital, Qilu Hospital of Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT05030870
Brief Title
Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients
Acronym
CapnoGI
Official Title
Capnographic Monitoring Decrease the Incidence of Hypoxia of the Elderly Patients Undergoing Gastrointestinal Endoscopy Procedure: a Randomized Multicenter Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
Henan Provincial People's Hospital, Qilu Hospital of Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Gastric Cancer, Gastric Polyp, Colon Polyp, Colon Cancer, Esophageal Cancer
Keywords
Capnographic Monitoring, Hypoxia, Gastrointestinal endoscopy, Elderly patients, Propofol
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Capnographic monitoring group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard monitoring group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Capnography monitoring
Intervention Description
Standard monitoring and capnographic monitoring.
Intervention Type
Device
Intervention Name(s)
Standard monitoring
Intervention Description
Standard monitoring but no capnographic monitoring
Primary Outcome Measure Information:
Title
The incidence of hypoxia
Description
(75% ≤ SpO2 < 90% for <60 s)
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary Outcome Measure Information:
Title
The incidence of sub-clinical respiratory depression
Description
(90% ≤ SpO2 < 95%)
Time Frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Title
The incidence of severe hypoxia
Description
(SpO2 < 75% or 75% ≤ SpO2 < 90% for >/=60 s)
Time Frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Title
The incidence of capnography curve decreased by half or more than the baseline and even disappeared without hypoxia
Description
capnography curve decreased by half or more than the baseline and even disappeared, SpO2 >90%
Time Frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Title
The incidence of other adverse events
Description
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Time Frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diansan Su, Dr.
Phone
+862168383702
Email
diansansu@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiuyue Lian, B.S.
Phone
+862168383702
Email
l18724464815@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diansan Su, Dr.
Organizational Affiliation
Department of Anesthesiology Renji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Provincial People's Hospital
City
Zhenzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaqiang Zhang, Dr.
Phone
13937121360
Email
hnmzxh@163.com
Facility Name
Qilu Hospital of Shandong University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianbo Wu, Dr.
Phone
18560083793
Email
jianbowu@126.com
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiuyue Lian, B.S.
Phone
+862168383702
Email
l18724464815@163.com
12. IPD Sharing Statement
Learn more about this trial
Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients
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