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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Heart Failure; Sepsis; Hemorrhage; Cardiac Arrest; Respiratory Distress Syndrome, Adult; Altered Mental Status
• Intervention / Treatment: Device: 731 Series Ventilator

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70807
      • East Baton Rouge EMS
  • Massachusetts
    • Uxbridge, Massachusetts, United States, 01569
      • Uxbridge Fire
  • Texas
    • Fort Worth, Texas, United States, 76116
      • Medstar
  • Washington
    • Rosedale, Washington, United States, 98332
      • Gig Harbor Fire Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Cases where participating EMS Agencies use ZOLL 731 Series ventilator in accordance with device labeling and Agency protocols in a pre-hospital setting

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Principal Investigator: Dan Godbee, MD, East Baton Rouge EMS

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Ventilation; Pre-Hospital
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hemorrhage; Acute Lung Injury
• Other Study ID Numbers: 76701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes