NCT00951704

Brief Summary

The prognosis of cardiac arrest patients is generally poor. Recent studies have showed that the high quality of CPR increases the survival after cardiac arrest. Therefore the investigators planned this prospective observational study to determine the epidemiology of sudden cardiac arrest in the prehospital setting of Tampere area, the quality of the CPR, and also the associations between depth and frequency of chest compressions and invasive arterial pressure, EtCO2,cerebral oxygenation and iatrogenic injuries associated to chest compressions 1) in patients resuscitated out of hospital by emergency medical service's (EMS's) personals and 2) in-hospital by hospital resuscitation team members. In addition, the investigators will analyze the effects of the chosen method of resuscitation on critical vital signs (Etco2 and invasive pressures): closed-chest CPR is compared to open-chest CPR, or mechanical CPR with a device (AutoPulse-CPR, Cardio Pump) compared to manual CPR guided with quality CPR device. The results will give the investigators important insights into the haemodynamics of CPR which may guide future strategies for the management of cardiac arrest. The research group is also interested in CPR related injuries and mattress effect. Quality of life after CA is evaluated among survivals and the cause of death among non-survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 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

November 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

7.1 years

First QC Date

July 31, 2009

Last Update Submit

December 12, 2018

Conditions

Cardiac Arrest

Keywords

CPRTissue Perfusioninvasive arterial pressureexhaled carbon dioxideQuality of lifeQuality of chest compressionsEpidemiology of sudden cardiac arrest(OHCA)

Outcome Measures

Primary Outcomes (2)

  • The success rate of current guidelines (depth and frequency of chest compression, epidemiology)

    During the resuscitation

  • Quality of life after CA

    Quality of life after CA is usually fairly good measurement of quality of resuscitation attempt

    6 months

Secondary Outcomes (2)

  • Invasive arterial pressures, cerebral oxygenation (NIRS), EtCO2

    During the resuscitation

  • survival of cardiac arrest

    hospital discharge

Other Outcomes (1)

  • Change in hemodynamics, Change in cerebral saturation, Change in quality of CPR

    During resuscitation

Study Arms (1)

Cardiac arrest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult population \>18 years of age with cardiac arrest

You may qualify if:

  • cardiac arrest
  • \> 18 years of age

You may not qualify if:

  • \< 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

Location

Department of Anesthesiology and Intensive Care, Turku University Hospital

Turku, 20100, Finland

Location

Related Publications (7)

  • Kangasniemi H, Setala P, Huhtala H, Kamarainen A, Virkkunen I, Jamsen E, Yli-Hankala A, Hoppu S. Out-of-hospital cardiac arrests in nursing homes and primary care facilities in Pirkanmaa, Finland. Acta Anaesthesiol Scand. 2018 Oct;62(9):1297-1303. doi: 10.1111/aas.13152. Epub 2018 May 29.

    PMID: 29845604DERIVED

  • Setala P, Hellevuo H, Huhtala H, Kamarainen A, Tirkkonen J, Hoppu S. Risk factors for cardiopulmonary resuscitation-related injuries sustained during out-of-hospital cardiac arrests. Acta Anaesthesiol Scand. 2018 Oct;62(9):1290-1296. doi: 10.1111/aas.13155. Epub 2018 May 24.

    PMID: 29797706DERIVED

  • Setala PA, Virkkunen IT, Kamarainen AJ, Huhtala HSA, Virta JS, Yli-Hankala AM, Hoppu SE. End-tidal carbon dioxide output in manual cardiopulmonary resuscitation versus active compression-decompression device during prehospital quality controlled resuscitation: a case series study. Emerg Med J. 2018 Jul;35(7):428-432. doi: 10.1136/emermed-2017-207103. Epub 2018 May 16.

    PMID: 29769232DERIVED

  • Sainio M, Hoppu S, Huhtala H, Eilevstjonn J, Olkkola KT, Tenhunen J. Simultaneous beat-to-beat assessment of arterial blood pressure and quality of cardiopulmonary resuscitation in out-of-hospital and in-hospital settings. Resuscitation. 2015 Nov;96:163-9. doi: 10.1016/j.resuscitation.2015.08.004. Epub 2015 Aug 24.

    PMID: 26310837DERIVED

  • Sainio M, Sutton RM, Huhtala H, Eilevstjonn J, Tenhunen J, Olkkola KT, Nadkarni VM, Hoppu S. Association of arterial blood pressure and CPR quality in a child using three different compression techniques, a case report. Scand J Trauma Resusc Emerg Med. 2013 Jul 2;21:51. doi: 10.1186/1757-7241-21-51.

    PMID: 23819769DERIVED

  • Sainio M, Kamarainen A, Huhtala H, Aaltonen P, Tenhunen J, Olkkola KT, Hoppu S. Real-time audiovisual feedback system in a physician-staffed helicopter emergency medical service in Finland: the quality results and barriers to implementation. Scand J Trauma Resusc Emerg Med. 2013 Jul 1;21:50. doi: 10.1186/1757-7241-21-50.

    PMID: 23816325DERIVED

  • Hoppu S, Sainio M, Huhtala H, Eilevstjonn J, Tenhunen J, Olkkola KT. Blood pressure during resuscitation in man--the effect of pause during rhythm analysis revisited. Resuscitation. 2011 Nov;82(11):1460-3. doi: 10.1016/j.resuscitation.2011.06.005. Epub 2011 Jun 17.

    PMID: 21764499DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jyrki Tenhunen, MD, PhD

    Critical Care Medicine Research Group

    STUDY DIRECTOR

  • Sanna Hoppu, MD, PhD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

  • Marko Sainio, MD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

  • Klaus Olkkola, MD, PhD

    Department of Anesthesiology and Intensive Care, Helsinki University Hospital

    STUDY DIRECTOR

  • Heidi Hellevuo, MD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

  • Piritta Setälä, MD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

  • Ilkka Virkkunen, MD, PhD

    Tampere University Hospital

    STUDY DIRECTOR

  • Heidi Kangasniemi, MD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

  • Joonas Tamminen

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2009

First Posted

August 4, 2009

Study Start

November 1, 2008

Primary Completion

December 1, 2015

Study Completion

December 1, 2018

Last Updated

December 13, 2018

Record last verified: 2018-12

Locations

FI(2)