Aerosolization During Upper Endoscopy

NCT ID: NCT06006078

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2021-10-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Endoscopic Facemask

Patients undergoing endoscopy with the use of an endoscopic facemask

Group Type: ACTIVE_COMPARATOR

Endoscopic Patient Facemask

Intervention Type: 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

No Endoscopic Facemask

Patients undergoing endoscopy without an endoscopic facemask

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

POM Mask

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anthony Lembo

OTHER

Sponsor Role: lead

Responsible Party

Anthony Lembo

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John Vargo, MD

Role: PRINCIPAL_INVESTIGATOR

Physician

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

21-641

Identifier Type: -

Identifier Source: org_study_id