NCT05604430

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
48mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Jun 2022Apr 2030

Study Start

First participant enrolled

June 30, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

7.8 years

First QC Date

July 11, 2022

Last Update Submit

August 12, 2025

Conditions

Keywords

VentilationPre-Hospital

Outcome Measures

Primary Outcomes (4)

  • Ventilator modes used

    Characterizing how often ventilator modes are used during mechanical ventilation

    Through study completion, an average 1 hour

  • Ventilator settings used

    Characterizing how often ventilator settings are changed during mechanical ventilation

    Through study completion, an average 1 hour

  • Ventilator Alarm type

    Characterize type of alarms triggered during mechanical ventilation

    Through study completion, an average 1 hour

  • Ventilator Alarm Frequency

    Characterize frequency of alarms triggered during mechanical ventilation

    Through study completion, an average 1 hour

Study Arms (1)

Ventilator patients

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

Device: 731 Series Ventilator

Interventions

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

Ventilator patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cases where participating EMS Agencies use ZOLL 731 Series ventilator in accordance with device labeling and Agency protocols in a pre-hospital setting

You may qualify if:

  • Ventilated using ZOLL 731 Series ventilator with Release 5 (or greater) software
  • Data recorded in ventilator data file

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

East Baton Rouge EMS

Baton Rouge, Louisiana, 70807, United States

Location

Uxbridge Fire

Uxbridge, Massachusetts, 01569, United States

Location

MedStar

Fort Worth, Texas, 76116, United States

Location

Gig Harbor Fire Department

Rosedale, Washington, 98332, United States

Location

MeSH Terms

Conditions

SepsisHeart FailureHemorrhageRespiratory Distress SyndromeHeart ArrestRespiratory Aspiration

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2022

First Posted

November 3, 2022

Study Start

June 30, 2022

Primary Completion (Estimated)

April 30, 2030

Study Completion (Estimated)

April 30, 2030

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations