Trial Outcomes & Findings for Biocontainment Device for Aerosol Generating Procedures (NCT NCT04532112)
NCT ID: NCT04532112
Last Updated: 2024-08-26
Results Overview
Measure the amount of time it take to perform an airway procedure (intubation) with or without the biocontainment device.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
Start of airway procedure through to completion of airway procedure.
Results posted on
2024-08-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
12
|
|
Overall Study
COMPLETED
|
22
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
Baseline Characteristics
Biocontainment Device for Aerosol Generating Procedures
Baseline characteristics by cohort
| Measure |
Intubated Subjects With the Biocontainment Device
n=25 Participants
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.
|
Intubated Subjects Without the Biocontainment Device
n=12 Participants
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.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
ASA status
ASA II
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
ASA status
ASA III
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 16.8 • n=5 Participants
|
56 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
chronic lung disease or moderate/severe asthma
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
cardiac disease
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
obstructive sleep apnea
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
diabetes
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
immunocompromised
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Mallampati
Mallampati 1
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Mallampati
Mallampati 2
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Mallampati
Mallampati 3
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Mallampati
Mallampati 4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
<20
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
BMI
20-24.99
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
BMI
25-29.99
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
BMI
30-34.99
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
BMI
35-39.99
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
BMI
40-44.99
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
BMI
>45
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
hyomental distance
normal
|
24 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
hyomental distance
short
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intubated Subjects With the Biocontainment Device
n=22 Participants
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.
|
Intubated Subjects Without the Biocontainment Device
n=12 Participants
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.
|
|---|---|---|
|
Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device.
|
46 time (seconds)
Standard Deviation 26.9
|
37 time (seconds)
Standard Deviation 13.1
|
PRIMARY outcome
Timeframe: collected at time of procedure, on average within 3 minutes of starting the procedureMeasure the number of adverse events, adverse device events associated with using the biocontainment device.
Outcome measures
| Measure |
Intubated Subjects With the Biocontainment Device
n=25 Participants
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.
|
Intubated Subjects Without the Biocontainment Device
n=12 Participants
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.
|
|---|---|---|
|
Quantifying the Number of AEs or ADEs to Assess Device Safety.
|
3 number of events
|
0 number of events
|
SECONDARY outcome
Timeframe: Survey completed up to 1 day after airway procedureAssess 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.
Outcome measures
| Measure |
Intubated Subjects With the Biocontainment Device
n=25 Participants
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.
|
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.
|
|---|---|---|
|
Median Likert Ratings From Device Use Survey Questions That Assess User Subject Device Comfort.
|
3 score on a scale
Standard Deviation 0.77
|
—
|
SECONDARY outcome
Timeframe: Survey completed up to 1 day after completion of airway procedureAssess 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.
Outcome measures
| Measure |
Intubated Subjects With the Biocontainment Device
n=25 Participants
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.
|
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.
|
|---|---|---|
|
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
|
—
|
SECONDARY outcome
Timeframe: Survey completed up to 1 day after airway procedureSurvey 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.
Outcome measures
| Measure |
Intubated Subjects With the Biocontainment Device
n=20 Participants
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.
|
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.
|
|---|---|---|
|
Median Likert Rating of the Patient Questionnaire Results to Assess Patient Experience in the Device.
|
4 score on a scale
Standard Deviation 0.87
|
—
|
Adverse Events
Intubated Subjects With the Biocontainment Device
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Intubated Subjects Without the Biocontainment Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intubated Subjects With the Biocontainment Device
n=25 participants at risk
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.
|
Intubated Subjects Without the Biocontainment Device
n=12 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
expected adverse event
|
8.0%
2/25 • Number of events 2 • adverse events were collected at the time of the procedure, on average within 3 minutes of starting the procedure.
|
0.00%
0/12 • adverse events were collected at the time of the procedure, on average within 3 minutes of starting the procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place