Pre-hospital Ventilation Clinical Study

NCT ID: NCT05604430

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-30

Study Completion Date

2030-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ventilator patients

Patients being ventilated by the ZOLL 731 Series ventilator in accordance with device labeling and Agency protocols in a pre-hospital setting.

731 Series Ventilator

Intervention Type DEVICE

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

Interventions

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731 Series Ventilator

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zoll Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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East Baton Rouge EMS

Baton Rouge, Louisiana, United States

Site Status

Uxbridge Fire

Uxbridge, Massachusetts, United States

Site Status

MedStar

Fort Worth, Texas, United States

Site Status

Gig Harbor Fire Department

Rosedale, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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76701

Identifier Type: -

Identifier Source: org_study_id

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