Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients

Gastric Cancer Clinical Trial

— CapnoGI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05030870
• Other study ID #: RenjiH-20201201
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colon Cancer
• Colon Polyp
• Esophageal Cancer
• Gastric Cancer
• Gastric Polyp
• Hypoxia
• Polyps

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