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Biocontainment Device for Aerosol Generating Procedures

NCT04532112 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-08-26

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Josh Atkins, Md, PhD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2021-07-30
Completion
2021-09-03

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04532112 on ClinicalTrials.gov