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Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (3)

Median Likert Ratings From Device Use Survey Questions That Assess User Subject Device Comfort.
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.
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 completed up to 1 day after airway procedure

Study Arms (2)

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.

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.

Device: Control for aerosol generating procedures

Interventions

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.

Intubated Subjects with the Biocontainment Device

Control for aerosol generating proceduresDevice

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

NONE

Purpose

PREVENTION

Intervention Model

PARALLEL

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

SPONSOR

Biocontainment Device for Aerosol Generating Procedures

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (2)

Intubated Subjects with the Biocontainment Device

Intubated Subjects without the Biocontainment Device

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (2)

Intubated Subjects with the Biocontainment Device

Intubated Subjects without the Biocontainment Device

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations