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

Study Overview
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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.

Official Title
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A Comparison of Conventional Adult Out-of-hospital Cardiopulmonary Resuscitation Against a Concept With Mechanical Chest Compressions and Simultaneous Defibrillation

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: LUCAS
* Other: Conventional manual resuscitation method


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1:Mechanical CPR with LUCAS<br>A Mechanical device that provides chest compressions | Device: LUCAS<br>* Mechanical chest compression<br>|
| Active Comparator: 2 Manual CPR<br>Manual chest compressions | Other: Conventional manual resuscitation method<br>* Manual compression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Four hour survival from successful restoration of spontaneous circulation. |  | Four hours survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPR, Mechanical, Manual, Survival, ROSC