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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Device: LUCAS; Other: Conventional manual resuscitation method

• Registration Number: NCT00609778
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-02-06
• Study First Posted: 2008-02-07
• Status Verified: 2011-06
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-10-04
• Last Update Posted: 2012-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1:Mechanical CPR with LUCAS	LUCAS	A Mechanical device that provides chest compressions
2 Manual CPR	Conventional manual resuscitation method	Manual chest compressions

Primary Outcome Measures

Name	Time	Method
Four hour survival from successful restoration of spontaneous circulation.	Four hours survival

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Stichting RAVU EMS; 🇳🇱 Utrecht, Netherlands

NHS, South Western Ambulance Service Trust (SWAST); 🇬🇧 Bournemouth, Poole & Dorchester, Dorset, United Kingdom

Kamber, Skåne; 🇸🇪 Malmö, Skåne, Sweden

Västerås EMS; 🇸🇪 Västerås, Sweden

Gävle EMS; 🇸🇪 Gävle, Sweden

Uppsala EMS; 🇸🇪 Uppsala, Sweden