Safety Issues Clinical Trial
Official title:
Does Use of a Facemask Reduce the Risk of Aerosolization During Anesthesia Assisted Upper Endoscopic Procedures: A Randomized Controlled Trial
NCT number | NCT06006078 |
Other study ID # | 21-641 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 31, 2021 |
Est. completion date | October 15, 2021 |
Verified date | August 2023 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 15, 2021 |
Est. primary completion date | October 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Start of endoscopy through the end of endoscopy |
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