Aerosol Disease, Droplet Spread, Protective Device (Physical Object)
Conditions
Keywords
PPE-personal protective equipment
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.
Interventions
DEVICEBiocontainment 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.
DEVICEControl 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.
Sponsors
Drexel University
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intubated Subjects With the Biocontainment Device Subjects undergoing scheduled airway procedures under general anesthesia with the Biocontainment Device by anesthesiologists trained in device use.
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. | 25 |
| Intubated Subjects Without the Biocontainment Device Subjects undergoing scheduled airway procedures under general anesthesia with the Biocontainment Device by anesthesiologists trained in device use.
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. | 12 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
Baseline characteristics
| Characteristic | Intubated Subjects With the Biocontainment Device | Total | Intubated Subjects Without the Biocontainment Device |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 16.8 | 53.7 years STANDARD_DEVIATION 14.4 | 56 years STANDARD_DEVIATION 9.1 |
| ASA status ASA II | 17 Participants | 25 Participants | 8 Participants |
| ASA status ASA III | 8 Participants | 12 Participants | 4 Participants |
| BMI <20 | 0 Participants | 3 Participants | 3 Participants |
| BMI 20-24.99 | 7 Participants | 10 Participants | 3 Participants |
| BMI 25-29.99 | 11 Participants | 13 Participants | 2 Participants |
| BMI 30-34.99 | 2 Participants | 4 Participants | 2 Participants |
| BMI 35-39.99 | 3 Participants | 4 Participants | 1 Participants |
| BMI 40-44.99 | 2 Participants | 3 Participants | 1 Participants |
| BMI >45 | 0 Participants | 0 Participants | 0 Participants |
| cardiac disease | 8 Participants | 11 Participants | 3 Participants |
| chronic lung disease or moderate/severe asthma | 3 Participants | 5 Participants | 2 Participants |
| diabetes | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 33 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| hyomental distance normal | 24 Participants | 35 Participants | 11 Participants |
| hyomental distance short | 1 Participants | 2 Participants | 1 Participants |
| immunocompromised | 0 Participants | 1 Participants | 1 Participants |
| Mallampati Mallampati 1 | 8 Participants | 11 Participants | 3 Participants |
| Mallampati Mallampati 2 | 12 Participants | 17 Participants | 5 Participants |
| Mallampati Mallampati 3 | 5 Participants | 9 Participants | 4 Participants |
| Mallampati Mallampati 4 | 0 Participants | 0 Participants | 0 Participants |
| obstructive sleep apnea | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 19 Participants | 27 Participants | 8 Participants |
| Region of Enrollment United States | 25 Participants | 37 Participants | 12 Participants |
| Sex: Female, Male Female | 17 Participants | 25 Participants | 8 Participants |
| Sex: Female, Male Male | 8 Participants | 12 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 12 |
| other Total, other adverse events | 3 / 25 | 0 / 12 |
| serious Total, serious adverse events | 0 / 25 | 0 / 12 |
Outcome results
Primary
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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intubated Subjects With the Biocontainment Device | Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device. | 46 time (seconds) | Standard Deviation 26.9 |
| Intubated Subjects Without the Biocontainment Device | Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device. | 37 time (seconds) | Standard Deviation 13.1 |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intubated Subjects With the Biocontainment Device | Quantifying the Number of AEs or ADEs to Assess Device Safety. | 3 number of events |
| Intubated Subjects Without the Biocontainment Device | Quantifying the Number of AEs or ADEs to Assess Device Safety. | 0 number of events |
Secondary
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
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intubated Subjects With the Biocontainment Device | Median Likert Rating of the Patient Questionnaire Results to Assess Patient Experience in the Device. | 4 score on a scale | Standard Deviation 0.87 |
Secondary
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
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intubated Subjects With the Biocontainment Device | Median Likert Ratings From Device Use Survey Questions That Assess User Subject Device Comfort. | 3 score on a scale | Standard Deviation 0.77 |
Secondary
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
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intubated Subjects With the Biocontainment Device | Median Likert Ratings From Device Use Survey Questions That Assess User Subject Healthcare Burden With the Device. | 4 score on a scale | Standard Deviation 0.84 |