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

NCT04864236 | Completed Results FDA Device

• 1 other identifier: 21-000022
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

health care worker exposure

Outcome Measures

Primary Outcomes (1)

• Particle Count Measurements During Intubation

  particle counts will be measured using a commercially-available particle counter at two locations: at the level of the anesthesiology provider's face (at the patient's head), and at the level of the assistant provider's face (at the patient's side)

  particle counts will be measured continuously from the time of patient's entry into the operating room until the patient has been intubated for surgery, approximately 15 minutes total

Secondary Outcomes (5)

• Time to Intubation

  during intubation

• Total Number of Intubation Attempts

  during intubation

• Pre-operative Airway Assessment (Mallampati Score)

  pre-operative assessment

• Laryngoscopy Grade View (Cormack-Lehane) Obtained During Intubation

  during intubation

• Pre-operative Airway Assessment (Thyromental Distance)

  pre-operative assessment

Study Arms (2)

Intervention group

EXPERIMENTAL

This group will undergo airway management in the operating room as part of the anesthesia for surgery in the presence of the novel isolation device.

Device: Novel isolation device to contain aerosol

Control group

NO INTERVENTION

Interventions

Novel isolation device to contain aerosol DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective scheduled surgery (not emergent)
• Planned general anesthesia requiring intubation

You may not qualify if:

• Patients refusing or unable to consent for any reason, including claustrophobia or inability to cooperate
• Patients predicted to require the use of fiberoptic bronchoscopy for intubation

Sponsors & Collaborators

• John Shin: lead

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Seger CD, Wang L, Dong X, Tebon P, Kwon S, Liew EC, Marijic J, Umar S, Hoftman NN. A Novel Negative Pressure Isolation Device for Aerosol Transmissible COVID-19. Anesth Analg. 2020 Sep;131(3):664-668. doi: 10.1213/ANE.0000000000005052.

  PMID: 32541251 BACKGROUND

Results Point of Contact

• Title: John Shin MD, Associate Clinical Professor
• Organization: UCLA Anesthesiology

JShin@mednet.ucla.edu

310-267-6629

Study Officials

• John Shin, MD

  University of California Los Angeles Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor of Anesthesiology

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 28, 2021
• Study Start: June 29, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 21, 2022
• Results First Posted: October 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)