Biocontainment Device for Aerosol Generating Procedures

University of Pennsylvania

Status: Completed

Conditions: Aerosol Disease; Droplet Spread; Protective Device (Physical Object)

Treatments: Device: Control for aerosol generating procedures; Device: Biocontainment Device For Aerosol Generating Procedures (Biobox)

Study type: Interventional

Funder types: Other

Identifiers

NCT04532112

843373

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups, including a placebo group

Intubated Subjects with the Biocontainment Device

Experimental group

Description:

Subjects undergoing scheduled airway procedures under general anesthesia with the Biocontainment Device by anesthesiologists trained in device use.

Treatment:

Device: Biocontainment Device For Aerosol Generating Procedures (Biobox)

Intubated Subjects without the Biocontainment Device

Placebo Comparator group

Description:

Subjects undergoing scheduled airway procedures under general anesthesia with the Biocontainment Device by same cohort of anesthesiologists trained in device use.

Treatment:

Device: Control for aerosol generating procedures