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Pre-hospital Ventilation Clinical Study

Pre-hospital Ventilation Clinical Study

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05604430
Enrollment
500
Registered
2022-11-03
Start date
2022-06-30
Completion date
2030-04-30
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Ventilation, Pre-Hospital

Brief summary

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

DEVICE731 Series Ventilator

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

Sponsors

Zoll Medical Corporation
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ventilator modes usedThrough study completion, an average 1 hourCharacterizing how often ventilator modes are used during mechanical ventilation
Ventilator settings usedThrough study completion, an average 1 hourCharacterizing how often ventilator settings are changed during mechanical ventilation
Ventilator Alarm typeThrough study completion, an average 1 hourCharacterize type of alarms triggered during mechanical ventilation
Ventilator Alarm FrequencyThrough study completion, an average 1 hourCharacterize frequency of alarms triggered during mechanical ventilation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026