Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
500 participants
OBSERVATIONAL
2022-06-30
2030-04-30
Brief Summary
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Detailed Description
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ZOLL will develop a methodology to collect and transfer ventilator data from the device to ZOLL to allow for a characterization of ventilator use in the pre-hospital setting. This knowledge and experience will subsequently be used to inform development of a mechanism to allow for automatic data collection and transmission from ZOLL ventilators to a central data repository. These data will be used to provide feedback, reporting, and benchmarking to individual agencies and departments on their ventilator use as well as aggregate use data from all ventilators to allow for comparisons.
Enrollment in this study is expected to take approximately 24 months. No patient outcome data will be collected.Participants are enrolled once data have been downloaded from the ventilator via RescueNet® VentReview software. Participants will not be followed after the assessment of study objectives.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Ventilator patients
Patients being ventilated by the ZOLL 731 Series ventilator in accordance with device labeling and Agency protocols in a pre-hospital setting.
731 Series Ventilator
FDA cleared ventilator indicated for use in the management of acute or chronic respiratory failure or during resuscitation.
Interventions
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731 Series Ventilator
FDA cleared ventilator indicated for use in the management of acute or chronic respiratory failure or during resuscitation.
Eligibility Criteria
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Inclusion Criteria
2. Data recorded in ventilator data file
Exclusion Criteria
ALL
No
Sponsors
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Zoll Medical Corporation
INDUSTRY
Responsible Party
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Locations
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East Baton Rouge EMS
Baton Rouge, Louisiana, United States
Uxbridge Fire
Uxbridge, Massachusetts, United States
MedStar
Fort Worth, Texas, United States
Gig Harbor Fire Department
Rosedale, Washington, United States
Countries
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Other Identifiers
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76701
Identifier Type: -
Identifier Source: org_study_id
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