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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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 26
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria: - children receiving anesthesia-related aerosol generating medical procedures Exclusion Criteria: - patients with positive COVID symptoms - positive preoperative COVID testing

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Disposable oxygen face tent
Disposable oxygen face tent used to minimize aerosol particles (through suction) during aerosol generating anesthesia procedures.

Locations

Country Name City State
United States Lucile Packard Childrens Hospital Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Aerosolized particle concentration in air To measure the particle concentrations in the air (µg/m^3), particle counters will be located at each of the different healthcare worker positions in the operating room (OR) during an aerosol generating procedure either with a local evacuation system or without one. Measurements will be taken every 30 seconds from prior to the patient entering the OR to patient departure from the OR. Up to 60 minutes
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