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

NCT ID: NCT04549623

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-27

Study Completion Date

2022-02-28

Brief Summary

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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

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Conditions

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Endoscopic Ultrasonography Sedation Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group ETCO2

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

Group Type EXPERIMENTAL

Novel end-tidal CO2 monitoring device

Intervention Type DEVICE

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

Group Reg

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

Group Type EXPERIMENTAL

SpO2 and respiratory motion monitoring

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

SpO2 and respiratory motion monitoring

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jia-feng Wang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Anesthesiology, Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jia-feng Wang, MD

Role: CONTACT

+862131161869

Facility Contacts

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Jia-feng Wang, M.D.

Role: primary

+86-21-31161853

Other Identifiers

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ETCO2-MDS

Identifier Type: -

Identifier Source: org_study_id

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