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Pediatric Source Control for Hazardous Particulate Exposure in Aerosol Generating Procedures

Pediatric Source Control for Hazardous Particulate Exposure in Aerosol Generating Procedures

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04577209
Enrollment
0
Registered
2020-10-06
Start date
2025-05-31
Completion date
2026-05-31
Last updated
2025-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Risk Reduction

Keywords

aerosol particles, anesthesia

Brief 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.

Detailed 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.

Interventions

DEVICEDisposable oxygen face tent

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

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* children receiving anesthesia-related aerosol generating medical procedures

Exclusion criteria

* patients with positive COVID symptoms * positive preoperative COVID testing

Design outcomes

Primary

MeasureTime frameDescription
Aerosolized particle concentration in airUp to 60 minutesTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026