Clincosm LogoSign in Get a demo

Aersosolization During Upper Endoscopy

Sponsor
The Cleveland Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT06006078
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
1.5
Actual Duration (Months)
40.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Endoscopic Patient Facemask
 N/A

Study Design

Study Type:
Interventional
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.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 :
Aug 31, 2021
Actual Primary Completion Date :
Oct 15, 2021
Actual Study Completion Date :
Oct 15, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Aersolization of particles during upper endoscopy [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Foundation Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • The Cleveland Clinic

    Investigators

    • Principal Investigator: John Vargo, MD, Physician

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    John Vargo, MD, The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT06006078
    Other Study ID Numbers:
    • 21-641
    First Posted:
    Aug 23, 2023
    Last Update Posted:
    Aug 23, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Intestinal Diseases
    Gastrointestinal Diseases
    Digestive System Diseases

    Study Results

    No Results Posted as of Aug 23, 2023