Clinical trial NCT04864236: An Isolation Device to Contain Aerosol During Aerosol Generating Procedures in the Operating Room
Official title: A Randomized Controlled Trial to Test a Novel Negative Pressure Isolation Device During Aerosol Generating Procedures in the Operating Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aerosol Containment
Aerosol Generating Procedure
Keywords: health care worker exposure
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Particle Count Measurements During Intubation
timeFrame: 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:
measure: Time to Intubation
timeFrame: during intubation
measure: Total Number of Intubation Attempts
timeFrame: during intubation
measure: Pre-operative Airway Assessment (Mallampati Score)
timeFrame: pre-operative assessment
measure: Laryngoscopy Grade View (Cormack-Lehane) Obtained During Intubation
timeFrame: during intubation
measure: Pre-operative Airway Assessment (Thyromental Distance)
timeFrame: pre-operative assessment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
Study officials:
affiliation: University of California Los Angeles Department of Anesthesiology
name: John Shin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.