An interventional study of Novel end-tidal CO2 monitoring device and SpO2 and respiratory motion monitoring in Endoscopic Ultrasonography, Sedation and Monitoring, sponsored by Changhai Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-14.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Prevention
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.
Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
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Novel end-tidal carbon dioxide monitoring device is used for sedation.
Device: Novel end-tidal CO2 monitoring device
Peripheral oxygen saturation (SpO2) and respiratory motion are regularly monitored during sedation.
Device: SpO2 and respiratory motion monitoring
Apart from SpO2 and respiratory motion monitoring, the EtCO2 monitoring device is used to detect CO2 from nose and mouth simultaneously.
Finger SpO2 and ECG-based respiratory motion monitoring are used during operation.
Peripheral oxygen saturation
Peripheral oxygen saturation is measured by pulse oximetry and hypoxemia is defined as SpO2≤91%
Time frame: Across the sedation, assessed up to 2 hours
Arterial pO2 and pCO2
The results of arterial blood gas measurements including partial pressure of oxygen (pO₂) and carbon dioxide (pCO₂)
Time frame: 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
Time frame: 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
Time frame: From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours
Recovery time
Duration of the recovery from sedation
Time frame: 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.
Time frame: 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.
Time frame: Across the procedure, assessed up to 2 hours
Plan to share: Undecided
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Changhai Hospital