Pre-hospital Ventilation Clinical Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 731 Series Ventilator.
- Who it may be relevant to
- Registry conditions: Altered Mental Status, Sepsis, Heart Failure, Hemorrhage. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This study will collect and characterize ventilator use during patient care with a ZOLL 731 Series ventilator in a pre-hospital setting.
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.
Interventions
- Device 731 Series Ventilator
FDA cleared ventilator indicated for use in the management of acute or chronic respiratory failure or during resuscitation.
Primary outcome measures
- Ventilator modes used [Time frame: Through study completion, an average 1 hour]
- Ventilator settings used [Time frame: Through study completion, an average 1 hour]
- Ventilator Alarm type [Time frame: Through study completion, an average 1 hour]
- Ventilator Alarm Frequency [Time frame: Through study completion, an average 1 hour]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 4 centers
- East Baton Rouge EMS — Baton Rouge
- Uxbridge Fire — Uxbridge
- MedStar — Fort Worth
- Gig Harbor Fire Department — Rosedale
Identifiers
NCT: NCT05604430 · 76701