Pre-hospital Ventilation Clinical Study

• Conditions: Heart Failure; Sepsis; Hemorrhage; Altered Mental Status; Respiratory Distress Syndrome, Adult; Cardiac Arrest
• Interventions: Device: 731 Series Ventilator

• Registration Number: NCT05604430
• Lead Sponsor: Zoll Medical Corporation

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.

Study Timeline

• Study Start: 2022-06-30
• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Ventilator modes used	Through study completion, an average 1 hour	Characterizing how often ventilator modes are used during mechanical ventilation
Ventilator settings used	Through study completion, an average 1 hour	Characterizing how often ventilator settings are changed during mechanical ventilation
Ventilator Alarm type	Through study completion, an average 1 hour	Characterize type of alarms triggered during mechanical ventilation
Ventilator Alarm Frequency	Through study completion, an average 1 hour	Characterize frequency of alarms triggered during mechanical ventilation

Trial Locations

Locations (1)

East Baton Rouge EMS; 🇺🇸 Baton Rouge, Louisiana, United States