Pre-hospital Ventilation Clinical Study
Study Details
Study Description
Brief Summary
This study will collect and characterize ventilator use during patient care with a ZOLL 731 Series ventilator in a pre-hospital setting.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ventilator patients 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
FDA cleared ventilator indicated for use in the management of acute or chronic respiratory failure or during resuscitation.
|
Outcome Measures
Primary Outcome Measures
- Ventilator modes used [Through study completion, an average 1 hour]
Characterizing how often ventilator modes are used during mechanical ventilation
- Ventilator settings used [Through study completion, an average 1 hour]
Characterizing how often ventilator settings are changed during mechanical ventilation
- Ventilator Alarm type [Through study completion, an average 1 hour]
Characterize type of alarms triggered during mechanical ventilation
- Ventilator Alarm Frequency [Through study completion, an average 1 hour]
Characterize frequency of alarms triggered during mechanical ventilation
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | East Baton Rouge EMS | Baton Rouge | Louisiana | United States | 70807 |
Sponsors and Collaborators
- Zoll Medical Corporation
Investigators
- Principal Investigator: Dan Godbee, MD, East Baton Rouge EMS
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 76701