Biocontainment Device for Aerosol Generating Procedures

Biocontainment Device With Aerosol Clearance for Aerosol Generating Procedures

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.

Study Overview

• Status: Completed
• Conditions: Droplet Spread; Protective Device (Physical Object); Aerosol Disease
• Intervention / Treatment: Device: Biocontainment Device For Aerosol Generating Procedures (Biobox); Device: Control for aerosol generating procedures

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intubated Subjects with the Biocontainment Device; 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); 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.
PLACEBO_COMPARATOR: Intubated Subjects without the Biocontainment Device; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Drexel University
• Investigators: Principal Investigator: Josh Atkins, Md, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 7, 2020
• Primary Completion (ACTUAL): July 30, 2021
• Study Completion (ACTUAL): September 3, 2021

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (ACTUAL): August 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: PPE-personal protective equipment
• Other Study ID Numbers: 843373

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: No