Pediatric Source Control for Hazardous Particulate Exposure in Aerosol Generating Procedures

NCT04577209 | Withdrawn FDA Device

• 1 other identifier: 57866
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Risk Reduction

Keywords

aerosol particles; anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pediatric Patients

EXPERIMENTAL

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.

Device: Disposable oxygen face tent

Interventions

Disposable oxygen face tent DEVICE

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

Pediatric Patients

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children receiving anesthesia-related aerosol generating medical procedures

You may not qualify if:

• patients with positive COVID symptoms
• positive preoperative COVID testing

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Childrens Hospital

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ban C Tsui, MD

  Stanford University

  STUDY DIRECTOR

• Stephanie Pan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 6, 2020
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)