A Comparison of Conventional Adult Out-of-Hospital Cardiopulmonary Resuscitation Against a Concept With Mechanical Chest Compressions and Simultaneous Defibrillation - LINC Study - Full Text View

Sponsors and Collaborators:	Jolife AB Uppsala University Hospital
Information provided by:	Jolife AB
ClinicalTrials.gov Identifier:	NCT00609778

Purpose

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

U.S. FDA Resources

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

Further study details as provided by Jolife AB:

Primary Outcome Measures:

Four hour survival from successful restoration of spontaneous circulation. [ Time Frame: Four hours survival ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	2500
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1:Mechanical CPR with LUCAS: Experimental A Mechanical device that provides chest compressions	Device: LUCAS Mechanical chest compression
2 Manual CPR: Active Comparator Manual chest compressions	Other: Conventional manual resuscitation method Manual compression

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609778

Contacts

Contact: Sten Rubertsson, Professor

+46 (0) 708693996

sten.rubertsson@akademiska.se

Locations

Netherlands
Stichting RAVU EMS	Recruiting
Utrecht, Netherlands
Contact: Rob Lichtveld, MD
Principal Investigator: Rob Lichtveld, MD
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
Sweden, Skåne
Kamber, Skåne	Recruiting
Malmö, Skåne, Sweden
Contact: Johan Silfverstolpe, MD
Principal Investigator: Johan Silfverstolpe, MD
United Kingdom, Dorset
NHS, South Western Ambulance Service Trust (SWAST)	Recruiting
Bournemouth, Poole & Dorchester, Dorset, United Kingdom
Contact: Martyn Box
Principal Investigator: Gillian M Bryce, MD

Sponsors and Collaborators

Jolife AB

Uppsala University Hospital

More Information

No publications provided

Responsible Party:	Jolife AB, ( Sponsor Jolife AB, Director of Clinical Affairs Fredrik Arnwald. )
Study ID Numbers:	Jolife 10-0
Study First Received:	January 25, 2008
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00609778 History of Changes
Health Authority:	Uppsala University and the Regional Ethical Review Board in Uppsala, Sweden:

Keywords provided by Jolife AB:

CPR
Mechanical
Manual
Survival
ROSC

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009