Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04577209 |
| Other study ID # |
57866 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2024 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
April 2023 |
| Source |
Stanford University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
There are two purposes of this study. The first purpose is to determine the exposure seen by
medical providers (e.g. anesthesiologists, surgeons, and nurses) to infectious and smoke
particulates generated during anesthesia-related aerosol generating medical procedures
(AGMPs) and pediatric otolaryngologic surgeries (with and without an intubated airway). The
second goal of this study is to apply a local exhaust ventilation system (LEVS) to
re-evaluate the exposure seen by the same medical providers during the same AGMPs and
surgeries.
Description:
Prior to the patient entering the OR, particle counters (Digital PM2.5 Air Quality detector,
ExGizmo, China) will ensure that the OR air quality has undergone the appropriate airflow
exchanges and thus will all read 0.
Measurements will be taken every 30 seconds. A research assistant in the periphery of the OR
will observe and record the following events: patient entrance into the OR, initiation of
mask induction, intubation, rotation of OR table for surgery, initiation of surgery,
completion of surgery, rotation of OR back to anesthesia, extubation, and patient departure
from the OR. The particle counters will be positioned accordingly: 1) at the level of the
patient's head, 2) at the level of the anesthesiologist/surgeon performing the AGMPs, 3) to
the right of the patient, 4) to the left of the patient, 5) at the anesthesia workstation,
and 6) at the circulating nurse's computer in the corner of the room. The particle counters
will continue with measurements until the patient exits the OR. For patients randomized to
the LEVS group, active suction will be provided through the use of a closed biohazardous
smoke evacuation system (Neptune 3, Stryker, Michigan, USA) equipped with an internal high
efficiency particulate air (HEPA) filter capable of capturing aerosolized particles as small
as 0.1 mm with 99.99% efficiency via suction power up to 25 cubic feet per minute air
exchange. The active suction will be positioned near the patient's airway without interfering
with the AGMP, and across from the location of the anesthesiologist or surgeon performing the
AGMP such that no HCW is positioned between the patient's airway and the suction device.
