Status:
COMPLETED
Aerosolization During Upper Endoscopy
Lead Sponsor:
Anthony Lembo
Conditions:
Infectious
Gastro-Intestinal Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 le...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2021
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT06006078
Start Date
August 31 2021
End Date
October 15 2021
Last Update
November 13 2025
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195