Biocontainment Device for Aerosol Generating Procedures

Aerosol Disease Clinical Trial

Official title: Biocontainment Device With Aerosol Clearance for Aerosol Generating Procedures

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04532112
• Study type: Interventional
• Source: University of Pennsylvania
• Status: Completed
• Phase: N/A
• Start date: December 7, 2020
• Completion date: September 3, 2021