Gastro-Intestinal Disorder, Infectious, Safety Issues
Conditions
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.
Interventions
DEVICEEndoscopic 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
Sponsors
Anthony Lembo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aerosolization of Particles During Upper Endoscopy | Start of endoscopy through the end of endoscopy | Comparing the aerosolization of particles of six different sizes \[0.3μm, 0.5μm, 1μm, 2μm, 5μm and 10μm\] during endoscopy between patients using an endoscopic facemask to those without. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endoscopic Facemask Patients undergoing endoscopy with the use of an endoscopic facemask
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 | 27 |
| No Endoscopic Facemask Patients undergoing endoscopy without an endoscopic facemask | 30 |
| Total | 57 |
Baseline characteristics
| Characteristic | Endoscopic Facemask | No Endoscopic Facemask | Total |
|---|---|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 17 | 59.6 years STANDARD_DEVIATION 16.7 | 59 years STANDARD_DEVIATION 16.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 12 Participants | 21 Participants | 33 Participants |
| Sex: Female, Male Male | 15 Participants | 9 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Aerosolization of Particles During Upper Endoscopy
Comparing the aerosolization of particles of six different sizes \[0.3μm, 0.5μm, 1μm, 2μm, 5μm and 10μm\] during endoscopy between patients using an endoscopic facemask to those without.
Time frame: Start of endoscopy through the end of endoscopy
Population: The data will be analyzed via stratification by particle size as a as a volumetric measurement of density: the number of particles per unit volume.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Endoscopic Facemask | Aerosolization of Particles During Upper Endoscopy | 0.3- 0.5 μm | 6.93 particle count per cubic ft |
| Endoscopic Facemask | Aerosolization of Particles During Upper Endoscopy | 0.7- 1.0 μm | 6.33 particle count per cubic ft |
| Endoscopic Facemask | Aerosolization of Particles During Upper Endoscopy | less than 0.3 μm | 9.86 particle count per cubic ft |
| Endoscopic Facemask | Aerosolization of Particles During Upper Endoscopy | 0.5- 0.7 μm | 5.63 particle count per cubic ft |
| Endoscopic Facemask | Aerosolization of Particles During Upper Endoscopy | 5.0 - 10 μm | 4.78 particle count per cubic ft |
| Endoscopic Facemask | Aerosolization of Particles During Upper Endoscopy | 1.0- 5.0 μm | 4.73 particle count per cubic ft |
| No Endoscopic Facemask | Aerosolization of Particles During Upper Endoscopy | 5.0 - 10 μm | 4.71 particle count per cubic ft |
| No Endoscopic Facemask | Aerosolization of Particles During Upper Endoscopy | less than 0.3 μm | 9.87 particle count per cubic ft |
| No Endoscopic Facemask | Aerosolization of Particles During Upper Endoscopy | 0.3- 0.5 μm | 7.05 particle count per cubic ft |
| No Endoscopic Facemask | Aerosolization of Particles During Upper Endoscopy | 0.5- 0.7 μm | 5.49 particle count per cubic ft |
| No Endoscopic Facemask | Aerosolization of Particles During Upper Endoscopy | 0.7- 1.0 μm | 6.34 particle count per cubic ft |
| No Endoscopic Facemask | Aerosolization of Particles During Upper Endoscopy | 1.0- 5.0 μm | 4.74 particle count per cubic ft |