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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
37
The intervention consists of a biocontainment and aerosol evacuation device (Biobox) that will be placed around a patient prior to the airway procedure and remain in place throughout the airway procedure. The Biobox device is manufactured by National Flag and consists of a re-useable frame with a disposable, plastic torso drape. This is a new device that has not been used previously in a healthcare setting.
There is no control device for the aerosol containment device. As such, intubation without a device will serve as the control/placebo arm for this trial.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device.
Measure the amount of time it take to perform an airway procedure (intubation) with or without the biocontainment device.
Time frame: Start of airway procedure through to completion of airway procedure.
Quantifying the Number of AEs or ADEs to Assess Device Safety.
Measure the number of adverse events, adverse device events associated with using the biocontainment device.
Time frame: collected at time of procedure, on average within 3 minutes of starting the procedure
Median Likert Ratings From Device Use Survey Questions That Assess User Subject Device Comfort.
Assess the user subject's comfort with using the biocontainment device. 5 point Likert scale (1. Strongly disagree, 2. disagree, 3. neutral, 4. agree, 5. strongly agree). data shown is median score of participants. A higher score would mean a better outcome.
Time frame: Survey completed up to 1 day after airway procedure
Median Likert Ratings From Device Use Survey Questions That Assess User Subject Healthcare Burden With the Device.
Assess for additional healthcare and cognitive burden imposed by the device. 5 point Likert scale (1. Strongly disagree, 2. disagree, 3. neutral, 4. agree, 5. strongly agree). data shown is median score of participants. A higher score would mean a worse outcome.
Time frame: Survey completed up to 1 day after completion of airway procedure
Median Likert Rating of the Patient Questionnaire Results to Assess Patient Experience in the Device.
Survey of patient's post-procedure on experience being inside the device. 5 point Likert scale (1. Strongly disagree, 2. disagree, 3. neutral, 4. agree, 5. strongly agree). data shown is median score of participants. A higher score means a better outcome.
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Time frame: Survey completed up to 1 day after airway procedure