N/A
N=57
Aerosolization During Upper Endoscopy
Infectious · Gastro-Intestinal Disorder · Safety Issues
Bottom Line
View on ClinicalTrials.gov: NCT06006078 ↗Enrolled (actual)
57
Serious AEs
—
Results posted
Nov 2025
Primary outcome: Primary: Aerosolization of Particles During Upper Endoscopy — 9.86; 9.87; 6.93; 7.05 particle count per cubic ft
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endoscopic Patient Facemask (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Anthony Lembo
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aerosolization of Particles During Upper Endoscopy |
9.86; 9.87; 6.93; 7.05; 5.63; 5.49 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT06006078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.