Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients (CapnoGI)

Shanghai Jiao Tong University

Status: Completed

Conditions: Gastric Polyp; Esophageal Cancer; Gastric Cancer; Colon Cancer; Hypoxia; Colon Polyp

Treatments: Device: Standard monitoring; Device: Capnography monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT05030870

RenjiH-20201201

Details and patient eligibility

About

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.

Enrollment: 1,800 patients

Sex: All

Ages: 65 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,800 participants in 2 patient groups

Capnographic monitoring group

Experimental group

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.

Treatment:

Device: Standard monitoring

Device: Capnography monitoring

Standard monitoring group

Active Comparator group

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.

Treatment:

Device: Standard monitoring