Clinical trial NCT00609778: A Comparison of Conventional Adult Out-of-hospital Cardiopulmonary Resuscitation Against a Concept With Mechanical Chest Compressions and Simultaneous Defibrillation - LINC Study
Official title: A Comparison of Conventional Adult Out-of-hospital Cardiopulmonary Resuscitation Against a Concept With Mechanical Chest Compressions and Simultaneous Defibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: CPR
Mechanical
Manual
Survival
ROSC
Lead sponsor: Jolife AB
Sponsor class: INDUSTRY
Collaborators: name: Uppsala University Hospital
First posted: 2008-02-07
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Four hour survival from successful restoration of spontaneous circulation.
timeFrame: Four hours survival
Secondary outcomes:
measure: 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).
timeFrame: 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
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Stichting RAVU EMS
city: Malmö
country: Sweden
facility: Kamber, Skåne
state: Skåne
city: Gävle
country: Sweden
facility: Gävle EMS
city: Uppsala
country: Sweden
facility: Uppsala EMS
city: Västerås
country: Sweden
facility: Västerås EMS
city: Bournemouth, Poole & Dorchester
country: United Kingdom
facility: NHS, South Western Ambulance Service Trust (SWAST)
state: Dorset
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.