Pre-hospital Ventilation Clinical Study

Study Overview
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Brief Summary
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This study will collect and characterize ventilator use during patient care with a ZOLL 731 Series ventilator in a pre-hospital setting.

Detailed Description
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This is a prospective, observational study. 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.

Official Title
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Pre-hospital Ventilation Clinical Study

Conditions
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Altered Mental Status, Sepsis, Heart Failure, Hemorrhage, Respiratory Distress Syndrome, Adult, Cardiac Arrest

Intervention / Treatment
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* Device: 731 Series Ventilator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidates for this study must meet all of the following Inclusion criteria: Ventilated using ZOLL 731 Series ventilator with Release 5 (or greater) software Data recorded in ventilator data file Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ventilator patients<br>Patients being ventilated by the ZOLL 731 Series ventilator in accordance with device labeling and Agency protocols in a pre-hospital setting. | Device: 731 Series Ventilator<br>* FDA cleared ventilator indicated for use in the management of acute or chronic respiratory failure or during resuscitation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator modes used | Characterizing how often ventilator modes are used during mechanical ventilation | Through study completion, an average 1 hour | 
| Ventilator settings used | Characterizing how often ventilator settings are changed during mechanical ventilation | Through study completion, an average 1 hour | 
| Ventilator Alarm type | Characterize type of alarms triggered during mechanical ventilation | Through study completion, an average 1 hour | 
| Ventilator Alarm Frequency | Characterize frequency of alarms triggered during mechanical ventilation | Through study completion, an average 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventilation, Pre-Hospital