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OpenTrials
Completed

NCT Number: NCT04532112

Biocontainment Device for Aerosol Generating Procedures

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.

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Key information

Conditions

Protective Device (Physical Object) Aerosol Disease Droplet Spread

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 procedures

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.

Primary outcomes

  1. Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device.

    Time frame: 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.

  2. Quantifying the Number of AEs or ADEs to Assess Device Safety.

    Time frame: 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 outcomes

  1. Median Likert Ratings From Device Use Survey Questions That Assess User Subject Device Comfort.

    Time frame: 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.

  2. Median Likert Ratings From Device Use Survey Questions That Assess User Subject Healthcare Burden With the Device.

    Time frame: 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.

  3. Median Likert Rating of the Patient Questionnaire Results to Assess Patient Experience in the Device.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Drexel University

Registry information

Official study title

Biocontainment Device With Aerosol Clearance for Aerosol Generating Procedures

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2020
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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