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Sponsors and Collaborators: |
Jolife AB Uppsala University Hospital |
Information provided by: | Jolife AB |
ClinicalTrials.gov Identifier: | NCT00609778 |
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 | Intervention |
Cardiovascular Diseases |
Device: LUCAS Other: Conventional manual resuscitation method |
MedlinePlus related topics: | CPR |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparison of Conventional Adult Out-of-Hospital Cardiopulmonary Resuscitation Against a Concept With Mechanical Chest Compressions and Simultaneous Defibrillation |
Estimated Enrollment: | 2500 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1:Mechanical CPR with LUCAS: Experimental
A Mechanical device that provides chest compressions
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Device: LUCAS
Mechanical chest compression
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2 Manual CPR: Active Comparator
Manual chest compressions
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Other: Conventional manual resuscitation method
Manual compression
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sten Rubertsson, Professor | +46 (0) 708693996 | sten.rubertsson@akademiska.se |
Sweden | |||||
Västerås EMS | Recruiting | ||||
Västerås, Sweden | |||||
Contact: Björn Ahlsteth, MD | |||||
Principal Investigator: Björn Ahlstedt, MD | |||||
Gävle EMS | Recruiting | ||||
Gävle, Sweden | |||||
Contact: Gunnar Skoog, MD | |||||
Principal Investigator: Gunnar Skoog, MD | |||||
Uppsala EMS | Recruiting | ||||
Uppsala, Sweden | |||||
Contact: Sten Rubertsson, Professor +46 (0) 708 693996 sten.rubertsson@akademiska.se | |||||
Principal Investigator: Sten Rubertsson, Professor |
Jolife AB |
Uppsala University Hospital |
Responsible Party: | Jolife AB, ( Sponsor Jolife AB, Director of Clinical Affairs Fredrik Arnwald. ) |
Study ID Numbers: | Jolife 10-0 |
First Received: | January 25, 2008 |
Last Updated: | February 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00609778 |
Health Authority: | Uppsala University and the Regional Ethical Review Board in Uppsala, Sweden: |
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