Pre-hospital Ventilation Clinical Study

N/AEnrolling By InvitationNCT05604430

Zoll Medical Corporation500 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

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

Interventions

731 Series VentilatorDEVICE

FDA cleared ventilator indicated for use in the management of acute or chronic respiratory failure or during resuscitation.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Candidates for this study must meet all of the following Inclusion criteria: 1. Ventilated using ZOLL 731 Series ventilator with Release 5 (or greater) software 2. Data recorded in ventilator data file Exclusion Criteria: * None

Locations (4)

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

Outcomes

Primary Outcomes

Ventilator modes used

Characterizing how often ventilator modes are used during mechanical ventilation

Time frame: Through study completion, an average 1 hour

Ventilator settings used

Characterizing how often ventilator settings are changed during mechanical ventilation

Time frame: Through study completion, an average 1 hour

Ventilator Alarm type

Characterize type of alarms triggered during mechanical ventilation

Time frame: Through study completion, an average 1 hour

Ventilator Alarm Frequency

Characterize frequency of alarms triggered during mechanical ventilation

Time frame: Through study completion, an average 1 hour

Data from ClinicalTrials.gov

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