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Aersosolization During Upper Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06006078
Recruitment Status : Completed
First Posted : August 23, 2023
Last Update Posted : August 23, 2023
Sponsor:
Information provided by (Responsible Party):
John Vargo, The Cleveland Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infectious Gastro-Intestinal Disorder Safety Issues Device: Endoscopic Patient Facemask Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One group of patients will be randomly assigned to receive an endoscopic facemask and one group of patients will undergo endoscopy without a facemask.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Use of a Facemask Reduce the Risk of Aerosolization During Anesthesia Assisted Upper Endoscopic Procedures: A Randomized Controlled Trial
Actual Study Start Date : August 31, 2021
Actual Primary Completion Date : October 15, 2021
Actual Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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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 Name: POM Mask
No Intervention: No Endoscopic Facemask
Patients undergoing endoscopy without an endoscopic facemask


Outcome Measures
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Primary Outcome Measures :
  1. Aersolization of particles during upper endoscopy [ Time Frame: Start of endoscopy through the end of endoscopy ]
    Comparing the aersolization of particles of six different sizes during endoscopy between patients using an endoscopic facemask to those without.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06006078


Locations
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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: John Vargo, MD Physician
  Study Documents (Full-Text)

Documents provided by John Vargo, The Cleveland Clinic:
Study Protocol and Statistical Analysis Plan  [PDF] April 2, 2021
Informed Consent Form  [PDF] October 21, 2022

More Information
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Responsible Party: John Vargo, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT06006078    
Other Study ID Numbers: 21-641
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: August 23, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases