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

A Randomized Controlled Trial to Test a Novel Negative Pressure Isolation Device During Aerosol Generating Procedures in the Operating Room

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.

Study Overview

• Status: Completed
• Conditions: Aerosol Containment; Aerosol Generating Procedure
• Intervention / Treatment: Device: Novel isolation device to contain aerosol

Detailed Description

Patients with SARS-CoV-2 infections may require procedures that generate infectious aerosols (suspension of tiny particles or droplets in the air). Aerosols are believed to be the primary method of spread of SARS-CoV-2, as well as many other communicable diseases. In the health care setting, the providers who are in close proximity to patients during these aerosol-generating procedures (ie. Intubation (tube in your throat to help you breathe), noninvasive positive pressure ventilation (breathing support administered through a face or nasal mask) methods such as continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), bronchoscopy (thin tube through nose or mouth into the lungs), high flow nasal cannula (oxygen delivery through the nose at a very high flow rate)) are at risk for becoming infected with SARS-CoV-2. The current standard of care to prevent the spread of virus to health care workers involves the use of N-95 respirators (particulate filtering facepiece respirators), which have been intermittently in short supply throughout the current COVID-19 pandemic. In addition, even when there are adequate supplies of N-95 respirators, health care workers have been reusing the respirators multiple times, which may result in decreased efficacy and potential viral exposure. In order to provide enhanced protection to health care workers during aerosol-generating procedures, the study investigators have created a device, named 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). Furthermore, SLACC is inexpensive, portable, and relatively simple to manufacture.

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. It is assembled using adhesive-backed polymer sections, allowing the structure to fold from a flat shipping/storage conformation into a free-standing structure. 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. Many other containment devices have been proposed during the COVID-19 pandemic, but none have been demonstrated to contain aerosols effectively. With external suction applied, the investigators believe SLACC vastly improves upon the aerosol containment ability of other devices. The investigators have tested SLACC in a simulated setting and recently published the results in a high-quality, peer-reviewed journal (PMID: 32541251).

The investigators propose to test the safety and efficacy of SLACC in containing contamination during aerosol-generating procedures in the operating room through a randomized controlled trial. The investigators have identified a method of objectively quantifying health care worker exposure to respiratory particles and plan to compare exposure to the number and size of respiratory particles when SLACC is used compared to the current standard of care (no device used).

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group
EXPERIMENTAL: Intervention group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Intubation	defined as time from the first entry of laryngoscope into pt's oropharynx to the time of confirmed successful tracheal intubation	during intubation
Total Number of Intubation Attempts	total number of intubation attempts during airway management	during intubation
Pre-operative Airway Assessment (Mallampati Score)	Mallampati score, can be given a score of 1-4 (whole numbers only), score of 4 indicates higher likelihood of difficult intubation and score of 1 indicates lower likelihood of difficult intubation	pre-operative assessment
Laryngoscopy Grade View (Cormack-Lehane) Obtained During Intubation	Cormack-Lehane grade assigned by anesthesiologist during intubation, grade can be 1-4, grade 1 correlates with a view of entirety of vocal cords while grade 4 correlates with no view at all of any part of the vocal cords	during intubation
Pre-operative Airway Assessment (Thyromental Distance)	thyromental distance is the distance measured between the chin and the thyroid cartilage (both landmarks are readily palpable on physical exam), this distance is typically measured in centimeters or as a measure of the number of finger breadths (as reported here). Finger breadths is defined as the number of finger widths that can fit within the defined distance.	pre-operative assessment

Collaborators and Investigators

• Sponsor: John Shin
• Investigators: Principal Investigator: John Shin, MD, University of California Los Angeles Department of Anesthesiology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2021
• Primary Completion (ACTUAL): September 1, 2021
• Study Completion (ACTUAL): September 1, 2021

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (ACTUAL): April 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 21, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: health care worker exposure
• Other Study ID Numbers: 21-000022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No