Aerosolization During Upper Endoscopy

October 30, 2025 updated by: Anthony Lembo

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endoscopic Facemask
Patients undergoing endoscopy with the use of an endoscopic facemask
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
Other Names:
  • POM Mask
No Intervention: No Endoscopic Facemask
Patients undergoing endoscopy without an endoscopic facemask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Start of endoscopy through the end of endoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthony Lembo

Investigators

  • Principal Investigator: John Vargo, MD, Physician

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2021

Primary Completion (Actual)

October 15, 2021

Study Completion (Actual)

October 15, 2021

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Estimated)

November 13, 2025

Last Update Submitted That Met QC Criteria

October 30, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-641

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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