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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06006078
Other study ID # 21-641
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 31, 2021
Est. completion date October 15, 2021

Study information

Verified date August 2023
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Given the current Covid-19 pandemic alongside the lack of evidence on aerosolization during upper endoscopy the investigators are conducting a randomized controlled trial seeking to assess both the level of aerosolization that occurs during these procedures along with determining if utilization of an endoscopic patient face-masks reduces the level of aerosolized particles. The protocol includes the use of a commercially available particle counter the investigators are employing for the measurement of aerosols before, during, and after anesthesia assisted upper endoscopic procedures. The investigators are recruiting patients undergoing these procedures with a target of 30 patients undergoing endoscopy without a facemask and 30 patients undergoing endoscopy with one.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 15, 2021
Est. primary completion date October 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients undergoing elective upper endoscopic procedures (upper endoscopy, ERCP, endoscopic ultrasound) with monitored anesthesia care at main campus Cleveland Clinic inpatient endoscopy unit. Exclusion Criteria: - Any patient requiring endotracheal intubation - Pregnant patients - Emergency procedures - Patients who require use of a facemask before or during the procedure due to medical necessity - Patients under the age of 18 - Non-English speaking individuals - Patients unable to provide consent. - Any procedure done outside the designated procedure room. - If in the opinion of the anesthesiologist, a subject who was randomized to the control arm requires placement of the procedural mask to augment oxygenation, the subject will be removed from the study

Study Design


Intervention

Device:
Endoscopic Patient Facemask
A commonly used endoscopic patient facemask that is normally used for oxygen delivery during endoscopy will be tested in this trial as a potential intervention for decreasing particle aerosolization

Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Aersolization of particles during upper endoscopy Comparing the aersolization of particles of six different sizes during endoscopy between patients using an endoscopic facemask to those without. Start of endoscopy through the end of endoscopy
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