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

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.

Study Overview

• Status: Unknown
• Conditions: Sedation; Monitoring; Endoscopic Ultrasonography
• Intervention / Treatment: Device: Novel end-tidal CO2 monitoring device; Device: SpO2 and respiratory motion monitoring

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Faculty of Anesthesiology, Changhai Hospital
      • Contact: Jia-feng Wang, M.D.; Phone Number: +86-21-31161853; Email: jfwang@smmu.edu.cn
      • Principal Investigator: Jia-feng Wang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group ETCO2; Novel end-tidal carbon dioxide monitoring device is used for sedation.	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.
Experimental: Group Reg; Peripheral oxygen saturation (SpO2) and respiratory motion are regularly monitored during sedation.	Device: SpO2 and respiratory motion monitoring; Finger SpO2 and ECG-based respiratory motion monitoring are used during operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial pO2 and pCO2	The results of arterial blood gas measurements including partial pressure of oxygen (pO₂) and carbon dioxide (pCO₂)	30 minutes after initiation of the sedation
The numbers of the times of body movement	The numbers of the times of any body movement across the procedure	From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours
Incidence of hypertension and hypotension	Hypertension or hypotension is defined as an increase or decrease in systolic blood pressure ≥20% compared to baseline values	From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours
Recovery time	Duration of the recovery from sedation	After termination of the sedation medication, assessed up to 2 hours
Total dosage of propofol	The patients are induced with 1.5~2.5mg/kg and maintained with 6~10mg/(kg•h) propofol. A propofol bolus dose range 0.2~0.5 mg/kg will be administered when needed.	Across the sedation, assessed up to 2 hours
Satisfaction score of the patients and endosonographers	Satisfaction score of the patients and endosonographers regarding to the sedation quality measured by a 0-100 visual analogue scale (VAS). 100 refers to the highest satisfaction degree while 0 refers to the worst satisfaction degree.	Across the procedure, assessed up to 2 hours

Collaborators and Investigators

• Sponsor: Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 10, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ETCO2-MDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No