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Aerosolization During Upper Endoscopy

NCT ID: NCT06006078

Last Updated: 2025-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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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

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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.

Detailed Description

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Conditions

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Infectious Gastro-Intestinal Disorder Safety Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group of patients will be randomly assigned to receive an endoscopic facemask and one group of patients will undergo endoscopy without a facemask.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

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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

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POM Mask

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anthony Lembo

OTHER

Sponsor Role lead

Responsible Party

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Anthony Lembo

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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John Vargo, MD

Role: PRINCIPAL_INVESTIGATOR

Physician

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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21-641

Identifier Type: -

Identifier Source: org_study_id