CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 37 enrolled
Drug / intervention
Biocontainment Device For Aerosol Generating Procedures (Biobox) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04532112
NCT04532112N/ACompleted
CompareCT.gov

Biocontainment Device With Aerosol Clearance for Aerosol Generating Procedures

University of Pennsylvania·interventional·Posted Aug 31, 2020·Updated Aug 26, 2024

In Brief

A clinical study evaluating Biocontainment Device For Aerosol Generating Procedures (Biobox) and Control for aerosol generating procedures for Protective Device (Physical Object) and 2 related conditions. Completed, enrolled 37 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProtective Device (Physical Object), Aerosol Disease, Droplet Spread
CountriesUnited States
CollaboratorsDrexel University

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 31, 2020
Enrollment StartDec 7, 2020
Primary CompletionJul 30, 2021
Study CompletionSep 3, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.8 years ago

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.

Control for aerosol generating proceduresdevice

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.