Aersosolization During Upper Endoscopy

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06006078
• Other study ID #: 21-641
• Status: Completed
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: October 15, 2021

Study information

• Verified date: August 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastro-Intestinal Disorder
• Gastrointestinal Diseases
• Infectious
• Intestinal Diseases
• Safety Issues

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

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