Pre-hospital Ventilation Clinical Study

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

Enrolling by Invitation

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Key information

Conditions

Altered Mental Status Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases Heart Failure Hemorrhage Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Distress Syndrome Respiratory Distress Syndrome, Adult Respiratory Tract Diseases Sepsis Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

East Baton Rouge EMS, Baton Rouge, Louisiana, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

731 Series Ventilator

Device

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

Primary outcomes

Ventilator modes used

Time frame: Through study completion, an average 1 hour

Characterizing how often ventilator modes are used during mechanical ventilation
Ventilator settings used

Time frame: Through study completion, an average 1 hour

Characterizing how often ventilator settings are changed during mechanical ventilation
Ventilator Alarm type

Time frame: Through study completion, an average 1 hour

Characterize type of alarms triggered during mechanical ventilation
Ventilator Alarm Frequency

Time frame: Through study completion, an average 1 hour

Characterize frequency of alarms triggered during mechanical ventilation

Sponsors and collaborators

Lead sponsor

Zoll Medical Corporation

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2030
Study completion: 2030
First posted: Nov 3, 2022
Registry last updated: Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting