End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography
- Conditions
- Endoscopic UltrasonographyMonitoringSedation
- Interventions
- Device: SpO2 and respiratory motion monitoringDevice: Novel end-tidal CO2 monitoring device
- Registration Number
- NCT04549623
- Lead Sponsor
- Changhai Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 480
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group Reg SpO2 and respiratory motion monitoring Peripheral oxygen saturation (SpO2) and respiratory motion are regularly monitored during sedation. Group ETCO2 Novel end-tidal CO2 monitoring device Novel end-tidal carbon dioxide monitoring device is used for sedation.
- Primary Outcome Measures
Name Time Method Peripheral oxygen saturation Across the sedation, assessed up to 2 hours Peripheral oxygen saturation is measured by pulse oximetry and hypoxemia is defined as SpO2≤91%
- Secondary Outcome Measures
Name Time Method Arterial pO2 and pCO2 30 minutes after initiation of the sedation The results of arterial blood gas measurements including partial pressure of oxygen (pO₂) and carbon dioxide (pCO₂)
Incidence of hypertension and hypotension From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours Hypertension or hypotension is defined as an increase or decrease in systolic blood pressure ≥20% compared to baseline values
Total dosage of propofol Across the sedation, assessed up to 2 hours 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.
The numbers of the times of body movement From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours The numbers of the times of any body movement across the procedure
Recovery time After termination of the sedation medication, assessed up to 2 hours Duration of the recovery from sedation
Satisfaction score of the patients and endosonographers Across the procedure, assessed up to 2 hours 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.
Trial Locations
- Locations (1)
Faculty of Anesthesiology, Changhai Hospital
🇨🇳Shanghai, Shanghai, China