NCT04532112

Biocontainment Device for Aerosol Generating Procedures

Biocontainment Device With Aerosol Clearance for Aerosol Generating Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2020-12-07
• Primary completion: 2021-07-30
• Completion: 2021-09-03
• First posted: 2020-08-31
• Last updated: 2024-08-26
• Results posted: 2024-08-26

Locations

1 site across 1 country: United States