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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

NCT ID: NCT00609778

Last Updated: 2012-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Keywords

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CPR Mechanical Manual Survival ROSC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1:Mechanical CPR with LUCAS

A Mechanical device that provides chest compressions

Group Type EXPERIMENTAL

LUCAS

Intervention Type DEVICE

Mechanical chest compression

2 Manual CPR

Manual chest compressions

Group Type ACTIVE_COMPARATOR

Conventional manual resuscitation method

Intervention Type OTHER

Manual compression

Interventions

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LUCAS

Mechanical chest compression

Intervention Type DEVICE

Conventional manual resuscitation method

Manual compression

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role collaborator

Jolife AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stichting RAVU EMS

Utrecht, , Netherlands

Site Status

Kamber, Skåne

Malmo, Skåne County, Sweden

Site Status

Gävle EMS

Gävle, , Sweden

Site Status

Uppsala EMS

Uppsala, , Sweden

Site Status

Västerås EMS

Västerås, , Sweden

Site Status

NHS, South Western Ambulance Service Trust (SWAST)

Bournemouth, Poole & Dorchester, Dorset, United Kingdom

Site Status

Countries

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Netherlands Sweden United Kingdom

References

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Rubertsson S, Lindgren E, Smekal D, Ostlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Bruins W, Ahlstedt B, Skoog G, Kastberg R, Halliwell D, Box M, Herlitz J, Karlsten R. Per-Protocol and Pre-Defined population analysis of the LINC study. Resuscitation. 2015 Nov;96:92-9. doi: 10.1016/j.resuscitation.2015.07.008. Epub 2015 Aug 3.

Reference Type DERIVED
PMID: 26247144 (View on PubMed)

Rubertsson S, Lindgren E, Smekal D, Ostlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R, Halliwell D, Box M, Herlitz J, Karlsten R. Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial. JAMA. 2014 Jan 1;311(1):53-61. doi: 10.1001/jama.2013.282538.

Reference Type DERIVED
PMID: 24240611 (View on PubMed)

Rubertsson S, Silfverstolpe J, Rehn L, Nyman T, Lichtveld R, Boomars R, Bruins W, Ahlstedt B, Puggioli H, Lindgren E, Smekal D, Skoog G, Kastberg R, Lindblad A, Halliwell D, Box M, Arnwald F, Hardig BM, Chamberlain D, Herlitz J, Karlsten R. The study protocol for the LINC (LUCAS in cardiac arrest) study: a study comparing conventional adult out-of-hospital cardiopulmonary resuscitation with a concept with mechanical chest compressions and simultaneous defibrillation. Scand J Trauma Resusc Emerg Med. 2013 Jan 25;21:5. doi: 10.1186/1757-7241-21-5.

Reference Type DERIVED
PMID: 23351178 (View on PubMed)

Other Identifiers

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Jolife 10-0

Identifier Type: -

Identifier Source: org_study_id