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

NCT04549623 | Unknown DMC

• 1 other identifier: ETCO2-MDS
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Ultrasonography; Sedation; Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Arterial pO2 and pCO2

  30 minutes after initiation of the sedation

• The numbers of the times of body movement

  From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours

• Incidence of hypertension and hypotension

  From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours

• Recovery time

  After termination of the sedation medication, assessed up to 2 hours

• Total dosage of propofol

  Across the sedation, assessed up to 2 hours

Study Arms (2)

Group ETCO2

EXPERIMENTAL

Novel end-tidal carbon dioxide monitoring device is used for sedation.

Device: Novel end-tidal CO2 monitoring device

Group Reg

EXPERIMENTAL

Peripheral oxygen saturation (SpO2) and respiratory motion are regularly monitored during sedation.

Device: SpO2 and respiratory motion monitoring

Interventions

Novel end-tidal CO2 monitoring device DEVICE

Apart from SpO2 and respiratory motion monitoring, the EtCO2 monitoring device is used to detect CO2 from nose and mouth simultaneously.

Group ETCO2

SpO2 and respiratory motion monitoring DEVICE

Finger SpO2 and ECG-based respiratory motion monitoring are used during operation.

Group Reg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Faculty of Anesthesiology, Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Central Study Contacts

Jia-feng Wang, MD

CONTACT

+862131161869; jfwang@smmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 16, 2020
• Study Start: September 27, 2020
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

CN (1)