Trial Outcomes & Findings for Aerosolization During Upper Endoscopy (NCT NCT06006078)
NCT ID: NCT06006078
Last Updated: 2025-11-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
Start of endoscopy through the end of endoscopy
Results posted on
2025-11-13
Participant Flow
Participant milestones
| Measure |
No Endoscopic Facemask
Patients undergoing endoscopy without an endoscopic facemask
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
27
|
|
Overall Study
COMPLETED
|
30
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Endoscopic Facemask
n=27 Participants
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
|
No Endoscopic Facemask
n=30 Participants
Patients undergoing endoscopy without an endoscopic facemask
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 17.0 • n=27 Participants
|
59.6 years
STANDARD_DEVIATION 16.7 • n=30 Participants
|
59 years
STANDARD_DEVIATION 16.7 • n=57 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=27 Participants
|
21 Participants
n=30 Participants
|
33 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=27 Participants
|
9 Participants
n=30 Participants
|
24 Participants
n=57 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Start of endoscopy through the end of endoscopyPopulation: 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.
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.
Outcome measures
| Measure |
Endoscopic Facemask
n=27 Participants
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
|
No Endoscopic Facemask
n=30 Participants
Patients undergoing endoscopy without an endoscopic facemask
|
|---|---|---|
|
Aerosolization of Particles During Upper Endoscopy
less than 0.3 μm
|
9.86 particle count per cubic ft
Interval 9.62 to 10.1
|
9.87 particle count per cubic ft
Interval 9.65 to 10.1
|
|
Aerosolization of Particles During Upper Endoscopy
0.5- 0.7 μm
|
5.63 particle count per cubic ft
Interval 5.32 to 5.93
|
5.49 particle count per cubic ft
Interval 5.19 to 5.78
|
|
Aerosolization of Particles During Upper Endoscopy
0.7- 1.0 μm
|
6.33 particle count per cubic ft
Interval 6.1 to 6.57
|
6.34 particle count per cubic ft
Interval 6.12 to 6.56
|
|
Aerosolization of Particles During Upper Endoscopy
1.0- 5.0 μm
|
4.73 particle count per cubic ft
Interval 4.62 to 4.84
|
4.74 particle count per cubic ft
Interval 4.63 to 4.84
|
|
Aerosolization of Particles During Upper Endoscopy
0.3- 0.5 μm
|
6.93 particle count per cubic ft
Interval 6.66 to 7.21
|
7.05 particle count per cubic ft
Interval 6.8 to 7.31
|
|
Aerosolization of Particles During Upper Endoscopy
5.0 - 10 μm
|
4.78 particle count per cubic ft
Interval 4.68 to 4.88
|
4.71 particle count per cubic ft
Interval 4.61 to 4.8
|
Adverse Events
Endoscopic Facemask
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Endoscopic Facemask
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place