Pediatric Source Control for Hazardous Particulate Exposure in Aerosol Generating Procedures

NCT ID: NCT04577209

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-05-31

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.

Conditions

Risk Reduction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pediatric Patients

Participants undergoing anesthesia-related aerosol generating medical procedures (AGMPs) and pediatric otolaryngologic surgeries will have a local exhaust ventilation system to the exposure seen by the medical providers during the AGMPs and surgeries.

Group Type: EXPERIMENTAL

Disposable oxygen face tent

Intervention Type: DEVICE

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

Interventions

Disposable oxygen face tent

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• children receiving anesthesia-related aerosol generating medical procedures

Exclusion Criteria

• patients with positive COVID symptoms
• positive preoperative COVID testing

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Chi-Ho Ban Tsui

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ban C Tsui, MD

Role: STUDY_DIRECTOR

Stanford University

Stephanie Pan, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Lucile Packard Childrens Hospital

Stanford, California, United States

Countries

United States

Other Identifiers

57866

Identifier Type: -

Identifier Source: org_study_id