NCT06006078

Aerosolization During Upper Endoscopy

Does Use of a Facemask Reduce the Risk of Aerosolization During Anesthesia Assisted Upper Endoscopic Procedures: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Anthony Lembo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infectious
• Gastro-Intestinal Disorder
• Safety Issues

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-08-31
• Primary completion: 2021-10-15
• Completion: 2021-10-15
• First posted: 2023-08-23
• Last updated: 2025-11-13
• Results posted: 2025-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study