Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04577209
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-18
First Post:
2020-09-28
Brief Title:
Pediatric Source Control for Hazardous Particulate Exposure in Aerosol Generating Procedures
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Pediatric Source Control for Hazardous Particulate Exposure in Aerosol Generating Procedures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are two purposes of this study The first purpose is to determine the exposure seen by medical providers eg 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
Detailed Description:
Prior to the patient entering the OR particle counters Digital PM25 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 patients head 2 at the level of the anesthesiologistsurgeon 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 nurses 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 01 mm with 9999 efficiency via suction power up to 25 cubic feet per minute air exchange The active suction will be positioned near the patients 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 patients airway and the suction device
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 patients head 2 at the level of the anesthesiologistsurgeon 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 nurses 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 01 mm with 9999 efficiency via suction power up to 25 cubic feet per minute air exchange The active suction will be positioned near the patients 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 patients airway and the suction device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None