Biocontainment Device for Aerosol Generating Procedures

Not Applicable

Completed

• Conditions: Protective Device (Physical Object); Droplet Spread; Aerosol Disease
• Interventions: Device: Biocontainment Device For Aerosol Generating Procedures (Biobox); Device: Control for aerosol generating procedures

• Registration Number: NCT04532112
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-31
• Study Start: 2020-12-07
• Primary Completion: 2021-07-30
• Study Completion: 2021-09-03
• Results First Submitted: 2023-06-07
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Results First Posted: 2024-08-26
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intubated Subjects with the Biocontainment Device	Biocontainment Device For Aerosol Generating Procedures (Biobox)	Subjects undergoing scheduled airway procedures under general anesthesia with the Biocontainment Device by anesthesiologists trained in device use.
Intubated Subjects without the Biocontainment Device	Control for aerosol generating procedures	Subjects undergoing scheduled airway procedures under general anesthesia with the Biocontainment Device by same cohort of anesthesiologists trained in device use.

Primary Outcome Measures

Name	Time	Method
Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device.	Start of airway procedure through to completion of airway procedure.	Measure the amount of time it take to perform an airway procedure (intubation) with or without the biocontainment device.
Quantifying the Number of AEs or ADEs to Assess Device Safety.	collected at time of procedure, on average within 3 minutes of starting the procedure	Measure the number of adverse events, adverse device events associated with using the biocontainment device.

Secondary Outcome Measures

Name	Time	Method
Median Likert Ratings From Device Use Survey Questions That Assess User Subject Device Comfort.	Survey completed up to 1 day after airway procedure	Assess the user subject's comfort with using the biocontainment device. 5 point Likert scale (1. Strongly disagree, 2. disagree, 3. neutral, 4. agree, 5. strongly agree). data shown is median score of participants. A higher score would mean a better outcome.
Median Likert Rating of the Patient Questionnaire Results to Assess Patient Experience in the Device.	Survey completed up to 1 day after airway procedure	Survey of patient's post-procedure on experience being inside the device. 5 point Likert scale (1. Strongly disagree, 2. disagree, 3. neutral, 4. agree, 5. strongly agree). data shown is median score of participants. A higher score means a better outcome.
Median Likert Ratings From Device Use Survey Questions That Assess User Subject Healthcare Burden With the Device.	Survey completed up to 1 day after completion of airway procedure	Assess for additional healthcare and cognitive burden imposed by the device. 5 point Likert scale (1. Strongly disagree, 2. disagree, 3. neutral, 4. agree, 5. strongly agree). data shown is median score of participants. A higher score would mean a worse outcome.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States