Biocontainment Device for Aerosol Generating Procedures

Aerosol Disease Clinical Trial

Official title:

Biocontainment Device With Aerosol Clearance for Aerosol Generating Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04532112
• Other study ID #: 843373
• Status: Completed
• Phase: N/A
• Start date: December 7, 2020
• Est. completion date: September 3, 2021

Study information

• Verified date: September 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 3, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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
Secondary	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