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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05604430
Other study ID # 76701
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 30, 2022
Est. completion date June 30, 2024

Study information

Verified date November 2022
Source Zoll Medical Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 500
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
731 Series Ventilator
FDA cleared ventilator indicated for use in the management of acute or chronic respiratory failure or during resuscitation.

Locations

Country Name City State
United States East Baton Rouge EMS Baton Rouge Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ventilator modes used Characterizing how often ventilator modes are used during mechanical ventilation Through study completion, an average 1 hour
Primary Ventilator settings used Characterizing how often ventilator settings are changed during mechanical ventilation Through study completion, an average 1 hour
Primary Ventilator Alarm type Characterize type of alarms triggered during mechanical ventilation Through study completion, an average 1 hour
Primary Ventilator Alarm Frequency Characterize frequency of alarms triggered during mechanical ventilation Through study completion, an average 1 hour
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