Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypoxia, Gastric Cancer, Gastric Polyp, Colon Polyp, Colon Cancer, Esophageal Cancer

Intervention / Treatment
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* Device: Capnography monitoring
* Device: Standard monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capnographic monitoring group<br>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<br>* Standard monitoring and capnographic monitoring.<br>Device: Standard monitoring<br>* Standard monitoring but no capnographic monitoring<br>|
| Active Comparator: Standard monitoring group<br>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<br>* Standard monitoring but no capnographic monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoxia, Capnographic Monitoring, Gastrointestinal endoscopy, Elderly patients, Propofol