Clinical trial NCT04532112: Biocontainment Device for Aerosol Generating Procedures
Official title: Biocontainment Device With Aerosol Clearance for Aerosol Generating Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protective Device (Physical Object)
Aerosol Disease
Droplet Spread
Keywords: PPE-personal protective equipment
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Drexel University
First posted: 2020-08-31
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention consists of a biocontainment and aerosol clearance device that will be tested in the controlled setting to assess feasibility to perform airway procedures under general anesthesia with the device. There is no specific control device for this product. The control condition for this intervention will consist of airway procedures per routine clinical protocols without the biocontainment device. This study will be performed initially in locations where a patient would undergo a scheduled airway procedure under general anesthesia on non-COVID-19 patients. All participants in this study as well as non-participants who are present in the room during the airway procedure (aerosol-generating procedure) will continue to use appropriate level of PPE per hospital protocols and policies. This device does not replace standard aerosol-protecting PPE.
Primary purpose: PREVENTION

Brief summary: The primary goal of this study is to assess use of a biocontainment device for planned airway procedures under general anesthesia. This will serve as a platform for using this device as a novel biocontainment and aerosol evacuation system as part of rapid sequence intubation protocols for COVID-19 patients. We hypothesize that airway procedures with the aerosol biocontainment device will be safe and effective with airway procedure times approaching times for airway procedures without the device.

Detailed description: This is a multi-site (two sites), unblinded, randomized, observational study performed in a controlled environment in the operating room. The hypothesis is that rapid sequence intubation or other urgent airway procedures performed with the biocontainment device will be safe and can be performed in an equivalent manner to urgent airway procedures without the biocontainment device. Methods to minimize bias include randomizing patients to intubation with or without the biocontainment device.

Eligibility criteria: Inclusion Criteria:

A) User (healthcare worker):

• Anesthesiologist, anesthesia resident, or CRNA at the Hospital of the University of Pennsylvania or PPMC who has signed and dated informed consent.

B) Patient:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* ASA I, II, III
* Undergoing planned procedure involving an airway procedure under general anesthesia

Exclusion Criteria:

A) User (healthcare worker):

• Pregnancy due to potential risks from lifting the device.

B) Patient:

* Known history of difficult airway
* Anticipated difficult airway management for any reason
* COVID-19 positive status
* Pregnancy
* Planned prolonged intubation post-surgery or anticipated inability to answer patient questionnaire within 1 week of intubation.

Primary outcomes:
measure: Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device.
timeFrame: Start of airway procedure through to completion of airway procedure.
measure: Quantifying the Number of AEs or ADEs to Assess Device Safety.
timeFrame: collected at time of procedure, on average within 3 minutes of starting the procedure
Secondary outcomes:
measure: Median Likert Ratings From Device Use Survey Questions That Assess User Subject Device Comfort.
timeFrame: Survey completed up to 1 day after airway procedure
measure: Median Likert Ratings From Device Use Survey Questions That Assess User Subject Healthcare Burden With the Device.
timeFrame: Survey completed up to 1 day after completion of airway procedure
measure: Median Likert Rating of the Patient Questionnaire Results to Assess Patient Experience in the Device.
timeFrame: Survey completed up to 1 day after airway procedure
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Josh Atkins, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: