Aerosolization During Upper Endoscopy

NCT06006078 | Completed Results DMC FDA Device

• 1 other identifier: 21-641
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious; Gastro-Intestinal Disorder; Safety Issues

Outcome Measures

Primary Outcomes (1)

• Aerosolization of Particles During Upper 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

Study Arms (2)

Endoscopic Facemask

ACTIVE COMPARATOR

Patients undergoing endoscopy with the use of an endoscopic facemask

Device: Endoscopic Patient Facemask

No Endoscopic Facemask

NO INTERVENTION

Patients undergoing endoscopy without an endoscopic facemask

Interventions

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

Also known as: POM Mask

Endoscopic Facemask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing elective upper endoscopic procedures (upper endoscopy, ERCP, endoscopic ultrasound) with monitored anesthesia care at main campus Cleveland Clinic inpatient endoscopy unit.

You may not qualify if:

• 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

Sponsors & Collaborators

• Anthony Lembo: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Communicable Diseases; Digestive System Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. John Vargo
• Organization: Cleveland Clinic Foundation

vargoj@ccf.org

2164455012

Study Officials

• John Vargo, MD

  Physician

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: One group of patients will be randomly assigned to receive an endoscopic facemask and one group of patients will undergo endoscopy without a facemask.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: August 23, 2023
• Study Start: August 31, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: November 13, 2025
• Results First Posted: November 13, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)