Biocontainment Device for Aerosol Generating Procedures

NCT ID: NCT04532112

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-07
• Study Completion Date: 2021-09-03

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intubated Subjects with the Biocontainment Device

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

Group Type: EXPERIMENTAL

Biocontainment Device For Aerosol Generating Procedures (Biobox)

Intervention Type: 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.

Intubated Subjects without the Biocontainment Device

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

Group Type: PLACEBO_COMPARATOR

Control for aerosol generating procedures

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Drexel University

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josh Atkins, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

843373

Identifier Type: -

Identifier Source: org_study_id