Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients

Not Applicable

Completed

• Conditions: Hypoxia; Gastric Polyp; Colon Cancer; Gastric Cancer; Colon Polyp; Esophageal Cancer
• Interventions: Device: Capnography monitoring; Device: Standard monitoring

• Registration Number: NCT05030870
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-26
• Study Start: 2021-09-01
• Study First Posted: 2021-09-01
• Primary Completion: 2022-09-01
• Study Completion: 2023-01-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capnographic monitoring group	Capnography monitoring	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.
Standard monitoring group	Standard monitoring	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.
Capnographic monitoring group	Standard monitoring	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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 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

Trial Locations

Locations (3)

Henan Provincial People's Hospital; 🇨🇳 Zhenzhou, Henan, China

Qilu Hospital of Shandong University; 🇨🇳 Qingdao, Shandong, China

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China