Biocontainment Device for Aerosol Generating Procedures

NCT04532112 | Completed Results

• 1 other identifier: 843373
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Protective Device (Physical Object); Aerosol Disease; Droplet Spread

Keywords

PPE-personal protective equipment

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  collected at time of procedure, on average within 3 minutes of starting the procedure

Secondary Outcomes (3)

• Median Likert Ratings From Device Use Survey Questions That Assess User Subject Device Comfort.

  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.

  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 completed up to 1 day after airway procedure

Study Arms (2)

Intubated Subjects with the Biocontainment Device

EXPERIMENTAL

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)

Intubated Subjects without the Biocontainment Device

PLACEBO COMPARATOR

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

Interventions

Biocontainment Device For Aerosol Generating Procedures (Biobox) DEVICE

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.

Intubated Subjects with the Biocontainment Device

Control for aerosol generating procedures DEVICE

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.

Intubated Subjects without the Biocontainment Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Drexel University: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Results Point of Contact

• Title: Dr. Michael Kohanski
• Organization: University of Pennsylvania

michael.kohanski@pennmedicine.upenn.edu

2153495766

Study Officials

• Josh Atkins, Md, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 31, 2020
• Study Start: December 7, 2020
• Primary Completion: July 30, 2021
• Study Completion: September 3, 2021
• Last Updated: August 26, 2024
• Results First Posted: August 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)