Aerosolization During Upper Endoscopy

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.

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Key information

Conditions

Infectious Communicable Diseases Digestive System Diseases Disease Attributes Gastro-Intestinal Disorder Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Safety Issues

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Patient Facemask

Device

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

Other names: POM Mask

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.

Sponsors and collaborators

Lead sponsor

Anthony Lembo

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Aug 23, 2023
Registry last updated: Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed