NCT04549623

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endoscopic Ultrasonography
• Sedation
• Monitoring

Interventions

Type	Name	Description
DEVICE	Novel end-tidal CO2 monitoring device	Apart from SpO2 and respiratory motion monitoring, the EtCO2 monitoring device is used to detect CO2 from nose and mouth simultaneously.
DEVICE	SpO2 and respiratory motion monitoring	Finger SpO2 and ECG-based respiratory motion monitoring are used during operation.

Timeline

• Start date: 2020-09-27
• Primary completion: 2021-12-01
• Completion: 2022-02-01
• First posted: 2020-09-16
• Last updated: 2020-10-14

Locations

1 site across 1 country: China