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

Naval Military Medical University

Status: Unknown

Conditions: Endoscopic Ultrasonography; Sedation; Monitoring

Treatments: Device: Novel end-tidal CO2 monitoring device; Device: SpO2 and respiratory motion monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04549623

ETCO2-MDS

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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480 participants in 2 patient groups

Group ETCO2

Experimental group

Description:

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

Treatment:

Device: Novel end-tidal CO2 monitoring device

Group Reg

Experimental group

Description:

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

Treatment:

Device: SpO2 and respiratory motion monitoring