NCT05604430

Pre-hospital Ventilation Clinical Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	731 Series Ventilator	FDA cleared ventilator indicated for use in the management of acute or chronic respiratory failure or during resuscitation.

Timeline

• Start date: 2022-06-30
• Primary completion: 2030-04-30
• Completion: 2030-04-30
• First posted: 2022-11-03
• Last updated: 2025-08-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study