Does Use of a Facemask Reduce the Risk of Aerosolization During Anesthesia Assisted Upper Endoscopic Procedures: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Anthony Lembo
- Enrollment
- 57
- Locations
- 2
- Primary Endpoint
- Aerosolization of Particles During Upper Endoscopy
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Aerosolization of Particles During Upper Endoscopy
Time Frame: Start of endoscopy through the end of endoscopy
Comparing the aerosolization of particles of six different sizes \[0.3μm, 0.5μm, 1μm, 2μm, 5μm and 10μm\] during endoscopy between patients using an endoscopic facemask to those without.
Secondary Outcomes
No secondary outcomes reported
Investigators
Anthony Lembo
MD
The Cleveland Clinic