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A Comparison of Conventional Adult Out-of-hospital Cardiopulmonary Resuscitation Against a Concept With Mechanical Chest Compressions and Simultaneous Defibrillation - LINC Study (LINC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00609778
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : October 5, 2012
Uppsala University Hospital
Information provided by (Responsible Party):
Jolife AB

Brief Summary:
The primary objective is to show superiority in survival of the modified method with the LUCAS Chest Compression System, compared to the conventional manual resuscitation method in patients suffering from out of hospital sudden cardiac arrest.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Device: LUCAS Other: Conventional manual resuscitation method Not Applicable

Detailed Description:

Every year 300 000 to 400 000 people suffer from sudden cardiac arrest outside of the hospital in Europe. Only 5 - 7 % of these patients survive and are discharged from hospital. In spite of massive education, research and new methods the survival rate has not improved. In the latest international guidelines for CPR, published in 2005, there is a strong emphasis on chest compressions with as little interruptions as possible. Manual chest compressions during CPR result in only 20-30% of normal blood flow and are difficult to perform for a long period of time. Mechanical chest compressions with the LUCAS device have shown increased blood flow in experimental studies. Defibrillation during ongoing mechanical compressions is a new method of treatment that showed promising results in increased short time survival in out of hospital cardiac arrest in a recently completed pilot study.

The LINC trial is a prospective randomised multicenter study where LUCAS according to a concept will be used with simultaneous defibrillation compared to manual chest compressions according to 2005 guidelines for advanced CPR. The study will be conducted in first tier systems, where LUCAS always will be placed in the first arriving ambulance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparison of Conventional Adult Out-of-hospital Cardiopulmonary Resuscitation Against a Concept With Mechanical Chest Compressions and Simultaneous Defibrillation
Study Start Date : January 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1:Mechanical CPR with LUCAS
A Mechanical device that provides chest compressions
Device: LUCAS
Mechanical chest compression

Active Comparator: 2 Manual CPR
Manual chest compressions
Other: Conventional manual resuscitation method
Manual compression

Primary Outcome Measures :
  1. Four hour survival from successful restoration of spontaneous circulation. [ Time Frame: Four hours survival ]

Secondary Outcome Measures :
  1. ROSC, Arrival to the emergency room with ROSC. Survival in hospital,Survival to hospital discharge Survival 1 and 6 months ( without severe neurological impairmen (CPC 1 or 2). [ Time Frame: Restoration of ROSC, Arrival to emergency room with ROSC, Survival to discharge from ICU, Survival to hospital discharge, Survival one and six months after SCA ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Unexpected adult out-of-hospital cardiac arrest where an attempt of resuscitation is considered appropriate.

Exclusion Criteria:

  • Traumatic cardiac arrest, including hanging
  • Age believed to be less than 18 years (no upper limit)
  • Known pregnancy
  • Defibrillated before LUCAS Chest Compressions System arrives at scene
  • Patients body size not fitting the LUCAS Chest Compression System

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00609778

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Stichting RAVU EMS
Utrecht, Netherlands
Kamber, Skåne
Malmö, Skåne, Sweden
Gävle EMS
Gävle, Sweden
Uppsala EMS
Uppsala, Sweden
Västerås EMS
Västerås, Sweden
United Kingdom
NHS, South Western Ambulance Service Trust (SWAST)
Bournemouth, Poole & Dorchester, Dorset, United Kingdom
Sponsors and Collaborators
Jolife AB
Uppsala University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jolife AB Identifier: NCT00609778     History of Changes
Other Study ID Numbers: Jolife 10-0
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: October 5, 2012
Last Verified: June 2011
Keywords provided by Jolife AB:
Additional relevant MeSH terms:
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Cardiovascular Diseases