Aersosolization During Upper Endoscopy

Study Overview
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Brief Summary
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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.

Official Title
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Does Use of a Facemask Reduce the Risk of Aerosolization During Anesthesia Assisted Upper Endoscopic Procedures: A Randomized Controlled Trial

Conditions
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Infectious, Gastro-Intestinal Disorder, Safety Issues

Intervention / Treatment
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* Device: Endoscopic Patient Facemask


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group of patients will be randomly assigned to receive an endoscopic facemask and one group of patients will undergo endoscopy without a facemask.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopic Facemask<br>Patients undergoing endoscopy with the use of an endoscopic facemask | Device: Endoscopic Patient Facemask<br>* 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<br>* Other names: POM Mask;|
| No Intervention: No Endoscopic Facemask<br>Patients undergoing endoscopy without an endoscopic facemask | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |