Protective Device (Physical Object)NCT04532112
Biocontainment Device for Aerosol Generating Procedures
A study testing Biocontainment Device For Aerosol Generating Procedures (Biobox) in people with Protective Device (Physical Object) and Aerosol Disease, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Protective Device (Physical Object), Aerosol Disease, Droplet Spread
- What is being tested?
- Biocontainment Device For Aerosol Generating Procedures (Biobox)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2020to 3 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- User (healthcare worker):
- Pregnancy due to potential risks from lifting the device.
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Biocontainment Device With Aerosol Clearance 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.
Read the 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.
- Being tested
- Biocontainment Device For Aerosol Generating Procedures (Biobox), Control for aerosol generating procedures
- Keywords
- PPE-personal protective equipment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 proceduresDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intubated Subjects with the Biocontainment Device | Experimental | Subjects undergoing scheduled airway procedures under general anesthesia with the Biocontainment Device by anesthesiologists trained in device use. Receives: Device: Biocontainment Device For Aerosol Generating Procedures (Biobox) |
| Intubated Subjects without the Biocontainment Device | Placebo comparator | Subjects undergoing scheduled airway procedures under general anesthesia with the Biocontainment Device by same cohort of anesthesiologists trained in device use. Receives: Device: Control for aerosol generating procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device.
Measure the amount of time it take to perform an airway procedure (intubation) with or without the biocontainment device.
Measured: Start of airway procedure through to completion of airway procedure.
Quantifying the Number of AEs or ADEs to Assess Device Safety.
Measure the number of adverse events, adverse device events associated with using the biocontainment device.
Measured: collected at time of procedure, on average within 3 minutes of starting the procedure
Secondary outcomes (3)
Median Likert Ratings From Device Use Survey Questions That Assess User Subject Device Comfort.
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.
Measured: Survey completed up to 1 day after airway procedure
Median Likert Ratings From Device Use Survey Questions That Assess User Subject Healthcare Burden With the Device.
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.
Measured: Survey completed up to 1 day after completion of airway procedure
Median Likert Rating of the Patient Questionnaire Results to Assess Patient Experience in the Device.
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.
Measured: Survey completed up to 1 day after airway procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start7 Dec 2020
- Primary completion30 Jul 2021
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Protective Device (Physical Object)Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention consists of a biocontainment and aerosol clearance device that will be tested in the controlled setting to assess feasibility to perform airway procedures under general anesthesia with the device. There is no specific control device for this product. The control condition for this intervention will consist of airway procedures per routine clinical protocols without the biocontainment device. This study will be performed initially in locations where a patient would undergo a scheduled airway procedure under general anesthesia on non-COVID-19 patients. All participants in this study as well as non-participants who are present in the room during the airway procedure (aerosol-generating procedure) will continue to use appropriate level of PPE per hospital protocols and policies. This device does not replace standard aerosol-protecting PPE.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Drexel University
- Responsible party
- Sponsor
- Investigators
- Josh Atkins, Md, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532112
- Sponsor's protocol ID
- 843373
- Status last verified
- Jul 2024
- First submitted
- 13 Aug 2020
- Last updated
- 26 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biocontainment Device With Aerosol Clearance for Aerosol Generating Procedures
- ClinicalTrials.gov ID
- NCT04532112
- Acronym / sponsor ID
- 843373
- Keywords
- PPE-personal protective equipment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Drexel University
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Posted 26 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention consists of a biocontainment and aerosol clearance device that will be tested in the controlled setting to assess feasibility to perform airway procedures under general anesthesia with the device. There is no specific control device for this product. The control condition for this intervention will consist of airway procedures per routine clinical protocols without the biocontainment device. This study will be performed initially in locations where a patient would undergo a scheduled airway procedure under general anesthesia on non-COVID-19 patients. All participants in this study as well as non-participants who are present in the room during the airway procedure (aerosol-generating procedure) will continue to use appropriate level of PPE per hospital protocols and policies. This device does not replace standard aerosol-protecting PPE.
| Arm | Type | Receives |
|---|---|---|
| Intubated Subjects with the Biocontainment Device | Experimental | 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 | Placebo comparator | Device: Control for aerosol generating proceduresSubjects undergoing scheduled airway procedures under general anesthesia with the Biocontainment Device by same cohort of anesthesiologists trained in device use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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
Key exclusion criteria (8 listed)
- User (healthcare worker):
- Pregnancy due to potential risks from lifting the device.
- Patient:
- Known history of difficult airway
- Anticipated difficult airway management for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Intubated Subjects with the Biocontainment Device |
| Control for aerosol generating proceduresThere 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. | Device | Intubated Subjects without the Biocontainment Device |
Primary outcome
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.
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.
3 secondary outcomes
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josh Atkins, Md, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biocontainment Device For Aerosol Generating Procedures (Biobox) in people with Protective Device (Physical Object) and Aerosol Disease, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.