End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography

Study Overview
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Brief Summary
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To meet the needs of both operators and patients, moderate and deep sedation has been widely used in digestive endoscopy, which is invasive and painful. With its pleasant effects, sedation has complications nevertheless. And respiratory depression is the most common one, which makes respiratory monitoring significant. SpO2 and respiratory motion are regularly monitored without satisfying timeliness or sensitivity. Capnography with current device is only able to detect either oral or nasal breathing. The present study was designed to test the effect of the investigator's modified End-Tidal Carbon Dioxide (ETCO2) monitoring device for sedation during endoscopic ultrasonography-guided fine needle aspiration.

Official Title
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The Effect of A Novel End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography-Guided Fine Needle Aspiration

Conditions
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Endoscopic Ultrasonography, Sedation, Monitoring

Intervention / Treatment
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* Device: Novel end-tidal CO2 monitoring device
* Device: SpO2 and respiratory motion monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for ultrasonography-guided fine needle aspiration Adult patients aged 18 to 65 years American Society of Anesthesiologists (ASA) Physical Status Classification I-III Subjects provide informed consent Exclusion Criteria: Full stomach or upper gastrointestinal tract obstruction Baseline pulse oximetric saturation (SpO2) <95% while breathing room air Obesity （BMI≥28kg/m2）or anticipated difficult airway Cardiovascular or cerebrovascular events within 3 months Pregnancy Chronic opioid user Allergic to anesthetics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Group ETCO2<br>Novel end-tidal carbon dioxide monitoring device is used for sedation. | Device: Novel end-tidal CO2 monitoring device<br>* Apart from SpO2 and respiratory motion monitoring, the EtCO2 monitoring device is used to detect CO2 from nose and mouth simultaneously.<br>|
| Experimental: Group Reg<br>Peripheral oxygen saturation (SpO2) and respiratory motion are regularly monitored during sedation. | Device: SpO2 and respiratory motion monitoring<br>* Finger SpO2 and ECG-based respiratory motion monitoring are used during operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral oxygen saturation | Peripheral oxygen saturation is measured by pulse oximetry and hypoxemia is defined as SpO2≤91% | Across the sedation, assessed up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial pO2 and pCO2 | The results of arterial blood gas measurements including partial pressure of oxygen (pO₂) and carbon dioxide (pCO₂) | 30 minutes after initiation of the sedation | 
| The numbers of the times of body movement | The numbers of the times of any body movement across the procedure | From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours | 
| Incidence of hypertension and hypotension | Hypertension or hypotension is defined as an increase or decrease in systolic blood pressure ≥20% compared to baseline values | From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours | 
| Recovery time | Duration of the recovery from sedation | After termination of the sedation medication, assessed up to 2 hours | 
| Total dosage of propofol | The patients are induced with 1.5 2.5mg/kg and maintained with 6 10mg/(kg•h) propofol. A propofol bolus dose range 0.2 0.5 mg/kg will be administered when needed. | Across the sedation, assessed up to 2 hours | 
| Satisfaction score of the patients and endosonographers | Satisfaction score of the patients and endosonographers regarding to the sedation quality measured by a 0-100 visual analogue scale (VAS). 100 refers to the highest satisfaction degree while 0 refers to the worst satisfaction degree. | Across the procedure, assessed up to 2 hours |