Back to resultsAersosolization During Upper Endoscopy
Primary Purpose
Infectious, Gastro-Intestinal Disorder, Safety Issues
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Patient Facemask
Sponsored by
About this trial
This is an interventional prevention trial for Infectious
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
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Endoscopic Facemask
No Endoscopic Facemask
Arm Description
Patients undergoing endoscopy with the use of an endoscopic facemask
Patients undergoing endoscopy without an endoscopic facemask
Outcomes
Primary Outcome Measures
Aersolization of particles during upper endoscopy
Comparing the aersolization of particles of six different sizes during endoscopy between patients using an endoscopic facemask to those without.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06006078
Brief Title
Aersosolization During Upper Endoscopy
Official Title
Does Use of a Facemask Reduce the Risk of Aerosolization During Anesthesia Assisted Upper Endoscopic Procedures: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious, Gastro-Intestinal Disorder, Safety Issues
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic Facemask
Arm Type
Active Comparator
Arm Description
Patients undergoing endoscopy with the use of an endoscopic facemask
Arm Title
No Endoscopic Facemask
Arm Type
No Intervention
Arm Description
Patients undergoing endoscopy without an endoscopic facemask
Intervention Type
Device
Intervention Name(s)
Endoscopic Patient Facemask
Other Intervention Name(s)
POM Mask
Intervention Description
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
Primary Outcome Measure Information:
Title
Aersolization of particles during upper endoscopy
Description
Comparing the aersolization of particles of six different sizes during endoscopy between patients using an endoscopic facemask to those without.
Time Frame
Start of endoscopy through the end of endoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Vargo, MD
Organizational Affiliation
Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Aersosolization During Upper Endoscopy
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