NCT04988906

Brief Summary

This is a before-and-after study examining the impact of real-time ventilation monitoring during out-of-hospital cardiac arrest. Study investigators will compare ventilation quality (rate, volume) performed during the resuscitation without the real-time feedback (before phase), to ventilation quality with the use of real-time feedback using the Zoll Accuvent device (after phase).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
412

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 10, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2023

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

1.6 years

First QC Date

July 16, 2021

Last Update Submit

November 17, 2025

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

VentilationCardiac ArrestResuscitation

Outcome Measures

Primary Outcomes (1)

  • Ventilation Volume

    Measurement of the volume of ventilation (mL) during resuscitation

    Day 1

Secondary Outcomes (3)

  • Feasibility of successfully using Zoll Accuvent device in the field Feasibility

    Day 1

  • Prehospital Return of spontaneous circulation (ROSC)

    Day 1

  • Ventilation Rate

    Day 1

Study Arms (2)

Before Arm

NO INTERVENTION

The before arm of the study prehospital providers will provide resuscitation as per standard practice. The providers will utilize the Zoll Accuvent device without activation of the real-time dashboard. This will allow us to collect baseline ventilation data.

After Arm

ACTIVE COMPARATOR

The after arm of the study the prehospital providers will provide resuscitation as per standard practice. The real-time ventilation dashboard will be activated and the providers will use real-time feedback to monitor ventilation quality during the resuscitation.

Device: Zoll Accuvent Ventilation Monitor

Interventions

Zoll Accuvent Ventilation MonitorDEVICE

Provides real-time ventilation quality monitoring (rate and volume)

After Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult out-of-hospital cardiac arrests treated by paramedics

You may not qualify if:

  • traumatic cardiac arrest
  • prehospital Do Not Resuscitate (DNR) orders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Science Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestRespiratory AspirationHeart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Before-and-After Design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2021

First Posted

August 4, 2021

Study Start

August 10, 2021

Primary Completion

March 8, 2023

Study Completion

March 8, 2023

Last Updated

November 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)