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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Device: LUCAS; Other: Conventional manual resuscitation method

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 Type: Interventional
• Enrollment (Actual): 2500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands
    • Stichting RAVU EMS
• Sweden
  • Gävle, Sweden
    • Gävle EMS
  • Uppsala, Sweden
    • Uppsala EMS
  • Västerås, Sweden
    • Västerås EMS
  • Skåne
    • Malmö, Skåne, Sweden
      • Kamber, Skåne
• United Kingdom
  • Dorset
    • Bournemouth, Poole & Dorchester, Dorset, United Kingdom
      • NHS, South Western Ambulance Service Trust (SWAST)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jolife AB
• Collaborators: Uppsala University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: January 25, 2008
• First Submitted That Met QC Criteria: February 6, 2008
• First Posted (Estimate): February 7, 2008

Study Record Updates

• Last Update Posted (Estimate): October 5, 2012
• Last Update Submitted That Met QC Criteria: October 4, 2012
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Survival; Mechanical; CPR; ROSC; Manual
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: Jolife 10-0