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

Sedation Clinical Trial

Official title:

The Effect of A Novel End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography-Guided Fine Needle Aspiration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04549623
• Other study ID #: ETCO2-MDS
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2020
• Est. completion date: February 2022

Study information

• Verified date: October 2020
• Source: Changhai Hospital
• Contact: Jia-feng Wang, MD
• Phone: +862131161869
• Email: jfwang[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: February 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Ultrasonography
• Monitoring
• Sedation

Intervention

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

Locations

Country	Name	City	State
China	Faculty of Anesthesiology, Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Recovery time	Duration of the recovery from sedation	After termination of the sedation medication, assessed up to 2 hours
Secondary	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
Secondary	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