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| Name | Class |
|---|---|
| Drexel University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | collected at time of procedure, on average within 3 minutes of starting the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Survey completed up to 1 day after airway procedure |
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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:
Exclusion Criteria:
A) User (healthcare worker):
• Pregnancy due to potential risks from lifting the device.
B) Patient:
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| Name | Affiliation | Role |
|---|---|---|
| Josh Atkins, Md, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Standard Deviation | time (seconds) | Start of airway procedure through to completion of airway procedure. |
|
adverse events were collected at the time of the procedure, on average within 3 minutes of starting the procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| expected adverse event | Surgical and medical procedures | Non-systematic Assessment | device removed due to subject anxiety and claustrophobia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Kohanski | University of Pennsylvania | 2153495766 | michael.kohanski@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2020 | Jun 6, 2023 | Prot_SAP_000.pdf |
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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.
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| 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. |
|
| 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. | 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. | Survey completed up to 1 day after airway procedure |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| chronic lung disease or moderate/severe asthma | Count of Participants | Participants |
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| cardiac disease | Count of Participants | Participants |
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| obstructive sleep apnea | Count of Participants | Participants |
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| diabetes | Count of Participants | Participants |
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| immunocompromised | Count of Participants | Participants |
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| ASA status | ASA status is the American Society of Anesthesiologists status for screening overall patient health in the context of a planned surgical procedure. Grading is as noted below ASA I: A normal healthy patient ASA II: A patient with mild systemic disease ASA III: A patient with severe systemic disease ASA IV: A patient with severe systemic disease that is a constant threat to life | Count of Participants | Participants |
|
| Mallampati | Mallampati score describes the size of the tongue base relative to oropharynx opening to characterize the amount of open space in the oropharynx. A grade of I is considered a wide open airway and a grade of IV is considered a crowded airway that is more likely to have airway obstruction. | Count of Participants | Participants |
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| BMI | Count of Participants | Participants |
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| hyomental distance | Count of Participants | Participants |
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| OG001 | 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. |
|
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| 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. | Posted | Number | number of events | collected at time of procedure, on average within 3 minutes of starting the procedure |
|
|
|
| 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. | Posted | Median | Standard Deviation | score on a scale | Survey completed up to 1 day after airway procedure |
|
|
|
| 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. | Posted | Median | Standard Deviation | score on a scale | Survey completed up to 1 day after completion of airway procedure |
|
|
|
| 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. | Posted | Median | Standard Deviation | score on a scale | Survey completed up to 1 day after airway procedure |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
|
| expected adverse event | Surgical and medical procedures | Non-systematic Assessment | difficult intubation. device removed to successfully perform intubation |
|
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