Pre-hospital Ventilation Clinical Study

Heart Failure Clinical Trial

Official title:

Pre-hospital Ventilation Clinical Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05604430
• Other study ID #: 76701
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Acute Lung Injury
• Altered Mental Status
• Cardiac Arrest
• Heart Failure
• Hemorrhage
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Sepsis

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