NCT00597207

Brief Summary

During resuscitation of out of hospital cardiac arrest patients the use of a mechanical chest compression device Autopulse will improve survival compared to manual compressions.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
4,231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
3 countries

5 active sites

Status
completed

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 Start

First participant enrolled

January 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 14, 2014

Completed
Last Updated

July 24, 2018

Status Verified

June 1, 2018

Enrollment Period

3.1 years

First QC Date

January 8, 2008

Results QC Date

March 8, 2014

Last Update Submit

June 25, 2018

Conditions

Cardiac ArrestCardiopulmonary Resuscitation

Keywords

CPRmechanicalmanualoutcomesurvivalquality

Outcome Measures

Primary Outcomes (1)

  • Hospital Discharge

    Whether a subject was discharged alive from the hospital or alternatively died prior to discharge.

    From time of first contact until hospital discharge, up to 90 days.

Study Arms (2)

1

EXPERIMENTAL

Mechanical CPR with AutoPulse

Device: AutoPulse

2

OTHER

Manual CPR

Other: Manual

Interventions

AutoPulseDEVICE

Mechanical device that provides chest compression

1
ManualOTHER

Manual chest compression

2

Eligibility Criteria

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

You may not qualify if:

  • Traumatic arrest (blunt, penetrating, burns)
  • Arrest due to exsanguinations, strangulation, smoke inhalation, drug overdose, electrocution, hanging, drowning.
  • Known or clinically apparent pregnancy
  • Do Not Attempt to Resuscitate (DNAR) orders
  • Apparent patient weight more than 225 kg (500 lbs)
  • Wards of the state
  • Prisoner
  • CPR device other than AutoPulse
  • These criteria will be determined in the best estimation of the rescue personnel, or if the AutoPulse signals that the patient is outside the parameters for AutoPulse deployment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hillsborough Fire Rescue

Tampa, Florida, 33610, United States

Location

Houston Fire

Houston, Texas, 77002, United States

Location

Gold Cross EMS

Menasha, Wisconsin, 54952, United States

Location

Vienna EMS

Vienna, Austria

Location

Nijmegen EMS

Nijmegen, Netherlands

Location

Related Publications (5)

  • Olsen JA, Brunborg C, Steinberg M, Persse D, Sterz F, Lozano M Jr, Westfall M, van Grunsven PM, Lerner EB, Wik L. Survival to hospital discharge with biphasic fixed 360 joules versus 200 escalating to 360 joules defibrillation strategies in out-of-hospital cardiac arrest of presumed cardiac etiology. Resuscitation. 2019 Mar;136:112-118. doi: 10.1016/j.resuscitation.2019.01.020. Epub 2019 Jan 29.

    PMID: 30708074DERIVED

  • Wik L, Olsen JA, Persse D, Sterz F, Lozano M Jr, Brouwer MA, Westfall M, Souders CM, Travis DT, Herken UR, Lerner EB. Why do some studies find that CPR fraction is not a predictor of survival? Resuscitation. 2016 Jul;104:59-62. doi: 10.1016/j.resuscitation.2016.04.013. Epub 2016 May 4.

    PMID: 27155547DERIVED

  • Steinberg MT, Olsen JA, Brunborg C, Persse D, Sterz F, Lozano M Jr, Brouwer MA, Westfall M, Souders CM, van Grunsven PM, Travis DT, Lerner EB, Wik L. Minimizing pre-shock chest compression pauses in a cardiopulmonary resuscitation cycle by performing an earlier rhythm analysis. Resuscitation. 2015 Feb;87:33-7. doi: 10.1016/j.resuscitation.2014.11.012. Epub 2014 Nov 21.

    PMID: 25461493DERIVED

  • Wik L, Olsen JA, Persse D, Sterz F, Lozano M Jr, Brouwer MA, Westfall M, Souders CM, Malzer R, van Grunsven PM, Travis DT, Whitehead A, Herken UR, Lerner EB. Manual vs. integrated automatic load-distributing band CPR with equal survival after out of hospital cardiac arrest. The randomized CIRC trial. Resuscitation. 2014 Jun;85(6):741-8. doi: 10.1016/j.resuscitation.2014.03.005. Epub 2014 Mar 15.

    PMID: 24642406DERIVED

  • Lerner EB, Persse D, Souders CM, Sterz F, Malzer R, Lozano M Jr, Westfall M, Brouwer MA, van Grunsven PM, Whitehead A, Olsen JA, Herken UR, Wik L. Design of the Circulation Improving Resuscitation Care (CIRC) Trial: a new state of the art design for out-of-hospital cardiac arrest research. Resuscitation. 2011 Mar;82(3):294-9. doi: 10.1016/j.resuscitation.2010.11.013. Epub 2010 Dec 31.

    PMID: 21196070DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Sr. Director of Clinical Research
Organization
ZOLL Medical Corporation
uherken@zoll.com
978-421-9655

Study Officials

  • Lars Wik, MD

    Ullevaal University Hospital

    PRINCIPAL INVESTIGATOR

  • David Persse, MD

    Houston Fire

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2008

First Posted

January 17, 2008

Study Start

January 1, 2008

Primary Completion

February 1, 2011

Study Completion

December 1, 2013

Last Updated

July 24, 2018

Results First Posted

April 14, 2014

Record last verified: 2018-06

Locations

NL(1)US(3)AU(1)