ClinicalTrials.gg
Enrolling by invitationNCT05604430Updated Sep 1, 2026

Pre-hospital Ventilation Clinical Study

An observational study in Altered Mental Status, Sepsis and Heart Failure, sponsored by Zoll Medical Corporation. Enrolling by invitation at 5 sites in United States. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Zoll Medical Corporation · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
500
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

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

Keywords

  • Ventilation
  • Pre-Hospital
03

In context

Sepsis

2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.

This study's planned enrollment of 500 is above the median of 150 across 1,162 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Zoll Medical Corporation is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Device731 Series Ventilator

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

06

What researchers measure

Primary outcomes

  1. Ventilator modes used

    Characterizing how often ventilator modes are used during mechanical ventilation

    Time frame: Through study completion, an average 1 hour

  2. Ventilator settings used

    Characterizing how often ventilator settings are changed during mechanical ventilation

    Time frame: Through study completion, an average 1 hour

  3. Ventilator Alarm type

    Characterize type of alarms triggered during mechanical ventilation

    Time frame: Through study completion, an average 1 hour

  4. Ventilator Alarm Frequency

    Characterize frequency of alarms triggered during mechanical ventilation

    Time frame: Through study completion, an average 1 hour

07

Study locations

5 sites
  • Aetna Ambulance Service, Inc
    Hartford, Connecticut 06106, United States
  • East Baton Rouge EMS
    Baton Rouge, Louisiana 70807, United States
  • Uxbridge Fire
    Uxbridge, Massachusetts 01569, United States
  • MedStar
    Fort Worth, Texas 76116, United States
  • Gig Harbor Fire Department
    Rosedale, Washington 98332, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2022 (actual). Primary completion is estimated for Apr 2030, 94 months after the start.

Of 52 industry-sponsored observational studies under Sepsis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 44. This study's planned 94 months is above that.

Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2022
First posted
Nov 3, 2022
StartActual
Jun 30, 2022
Primary completionEst.
Apr 30, 2030
CompletionEst.
Apr 30, 2030
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05604430
Responsible party
Sponsor
First posted
Nov 3, 2022
Start date
Jun 30, 2022
Primary completion
Apr 30, 2030 (estimated)
Completion
Apr 30, 2030 (estimated)
Last update
Sep 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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