An interventional study of Biocontainment Device For Aerosol Generating Procedures (Biobox) and Control for aerosol generating procedures in Protective Device (Physical Object), Aerosol Disease and Droplet Spread, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention
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.
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.
University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
A) User (healthcare worker):
B) Patient:
Exclusion Criteria:
A) User (healthcare worker):
B) Patient:
Subjects undergoing scheduled airway procedures under general anesthesia with the Biocontainment Device by anesthesiologists trained in device use.
Device: Biocontainment Device For Aerosol Generating Procedures (Biobox)
Subjects undergoing scheduled airway procedures under general anesthesia with the Biocontainment Device by same cohort of anesthesiologists trained in device use.
Device: Control for aerosol generating procedures
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.
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.
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.
Time frame: 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.
Time frame: collected at time of procedure, on average within 3 minutes of starting the procedure
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.
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.
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.
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.
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.
Time frame: Survey completed up to 1 day after airway procedure
| Milestone | Intubated Subjects With the Biocontainment Device | Intubated Subjects Without the Biocontainment Device |
|---|---|---|
| Started | 25 | 12 |
| Completed | 22 | 12 |
| Not completed | 3 | 0 |
| Withdrew: Adverse event | 3 | 0 |
Measure the amount of time it take to perform an airway procedure (intubation) with or without the biocontainment device.
| time (seconds) | Intubated Subjects With the Biocontainment Device | Intubated Subjects Without the Biocontainment Device |
|---|---|---|
| Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device. | 46 ± 26.9 | 37 ± 13.1 |
Measure the number of adverse events, adverse device events associated with using the biocontainment device.
| number of events | Intubated Subjects With the Biocontainment Device | Intubated Subjects Without the Biocontainment Device |
|---|---|---|
| Quantifying the Number of AEs or ADEs to Assess Device Safety. | 3 | 0 |
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.
| score on a scale | Intubated Subjects With the Biocontainment Device |
|---|---|
| Median Likert Ratings From Device Use Survey Questions That Assess User Subject Device Comfort. | 3 ± 0.77 |
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.
| score on a scale | Intubated Subjects With the Biocontainment Device |
|---|---|
| Median Likert Ratings From Device Use Survey Questions That Assess User Subject Healthcare Burden With the Device. | 4 ± 0.84 |
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.
| score on a scale | Intubated Subjects With the Biocontainment Device |
|---|---|
| Median Likert Rating of the Patient Questionnaire Results to Assess Patient Experience in the Device. | 4 ± 0.87 |
Collected over adverse events were collected at the time of the procedure, on average within 3 minutes of starting the procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intubated Subjects With the Biocontainment Device | 0/25 (0%) | 0/25 (0%) | 3/25 (12%) |
| Intubated Subjects Without the Biocontainment Device | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Event | Intubated Subjects With the Biocontainment Device | Intubated Subjects Without the Biocontainment Device |
|---|---|---|
| expected adverse eventSurgical and medical procedures | 2/25 | 0/12 |
| expected adverse eventSurgical and medical procedures | 1/25 | 0/12 |
| Age, Continuous(years) | Intubated Subjects With the Biocontainment Device | Intubated Subjects Without the Biocontainment Device | Total |
|---|---|---|---|
| Mean | 52 ± 16.8 | 56 ± 9.1 | 53.7 ± 14.4 |
| Sex: Female, Male(Participants) | Intubated Subjects With the Biocontainment Device | Intubated Subjects Without the Biocontainment Device | Total |
|---|---|---|---|
| Female | 17 | 8 | 25 |
| Male | 8 | 4 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Intubated Subjects With the Biocontainment Device | Intubated Subjects Without the Biocontainment Device | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 22 | 11 | 33 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Intubated Subjects With the Biocontainment Device | Intubated Subjects Without the Biocontainment Device | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 3 | 7 |
| White | 19 | 8 | 27 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Intubated Subjects With the Biocontainment Device | Intubated Subjects Without the Biocontainment Device | Total |
|---|---|---|---|
| United States | 25 | 12 | 37 |
| chronic lung disease or moderate/severe asthma(Participants) | Intubated Subjects With the Biocontainment Device | Intubated Subjects Without the Biocontainment Device | Total |
|---|---|---|---|
| Count of participants | 3 | 2 | 5 |
| cardiac disease(Participants) | Intubated Subjects With the Biocontainment Device | Intubated Subjects Without the Biocontainment Device | Total |
|---|---|---|---|
| Count of participants | 8 | 3 | 11 |
| obstructive sleep apnea(Participants) | Intubated Subjects With the Biocontainment Device | Intubated Subjects Without the Biocontainment Device | Total |
|---|---|---|---|
| Count of participants | 4 | 1 | 5 |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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