Biocontainment Device for Aerosol Generating Procedures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Biocontainment Device With Aerosol Clearance for Aerosol Generating Procedures

Conditions
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Protective Device (Physical Object), Aerosol Disease, Droplet Spread

Intervention / Treatment
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* Device: Biocontainment Device For Aerosol Generating Procedures (Biobox)
* Device: Control for aerosol generating procedures


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intubated Subjects with the Biocontainment Device<br>Subjects undergoing scheduled airway procedures under general anesthesia with the Biocontainment Device by anesthesiologists trained in device use. | Device: Biocontainment Device For Aerosol Generating Procedures (Biobox)<br>* 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.<br>|
| Placebo Comparator: Intubated Subjects without the Biocontainment Device<br>Subjects undergoing scheduled airway procedures under general anesthesia with the Biocontainment Device by same cohort of anesthesiologists trained in device use. | Device: Control for aerosol generating procedures<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the time for performing an airway procedure with the biocontainment device when accounting for patient and user-specific factors. Sub-analysis, based on user experience level. | Assess changes in airway procedure times with and without the biocontainment device as a function of repeated utilization and as a function of patient-associated airway factors (Mallampati score, hyomental distance, neck mobility, BMI) and user-associated airway factors (experience of user, airway device used, induction sequence). | Start of airway procedure through to completion of airway procedure. | 
| Quantifying the number of AEs or ADEs over time to assess device safety. Breakdown of AEs/ADEs as a function of time and by user subject. | Assess adverse events, adverse device events associated with using the biocontainment device. | through study completion, an average of 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At time of consent through 1 week after completion of 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. | At time of consent through 1 week 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. | At time of consent through 1 week after completion of airway procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PPE-personal protective equipment