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An Isolation Device to Contain Aerosol During Aerosol Generating Procedures in the Operating Room

NCT04864236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2022-10-21

Study results available
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Summary

The purpose of this study is to test the safety and efficacy of a new isolation device to contain aerosol during aerosol-generating procedures in the operating room.

Conditions

  • Aerosol Containment
  • Aerosol Generating Procedure

Interventions

DEVICE

Novel isolation device to contain aerosol

The novel isolation device is called SLACC (Suction-assisted Local Aerosol Containment Chamber). SLACC has the ability to isolate the atmosphere around the patient's upper airway (nose, mouth, throat) via negative pressure in a manner analogous to isolation rooms used to house patients with communicable diseases spread by aerosol (e.g. tuberculosis). The SLACC uses an external suction source to maintain a negative pressure micro-atmosphere around a patient's head (the source of infectious aerosols). The components of SLACC include a clear polymer frame, a flexible drape, and integrated sealed arm sleeves to protect the hands and forearms of the health care provider. The structure is flexible during use, transparent, can be rapidly assembled, and easily collapsible for removal and transport. Once deployed with the patient's head inside the chamber, the drape is secured across the open side of the chamber with adhesive and covers the patient's torso.

Sponsors & Collaborators

  • John Shin

    lead OTHER

Principal Investigators

  • John Shin, MD · University of California Los Angeles Department of Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2021-09-01
Completion
2021-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04864236 on ClinicalTrials.gov