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

NCT04549623 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2020-10-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Changhai Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-27
Primary Completion
2021-12-31
Completion
2022-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04549623 on ClinicalTrials.gov