NCT00609778

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 5, 2012

Status Verified

June 1, 2011

Enrollment Period

4.6 years

First QC Date

January 25, 2008

Last Update Submit

October 4, 2012

Conditions

Cardiovascular Diseases

Keywords

CPRMechanicalManualSurvivalROSC

Outcome Measures

Primary Outcomes (1)

  • Four hour survival from successful restoration of spontaneous circulation.

    Four hours survival

Secondary Outcomes (1)

  • 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

Study Arms (2)

1:Mechanical CPR with LUCAS

EXPERIMENTAL

A Mechanical device that provides chest compressions

Device: LUCAS

2 Manual CPR

ACTIVE COMPARATOR

Manual chest compressions

Other: Conventional manual resuscitation method

Interventions

LUCASDEVICE

Mechanical chest compression

1:Mechanical CPR with LUCAS
Conventional manual resuscitation methodOTHER

Manual compression

2 Manual CPR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unexpected adult out-of-hospital cardiac arrest where an attempt of resuscitation is considered appropriate.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Stichting RAVU EMS

Utrecht, Netherlands

Location

Kamber, Skåne

Malmo, Skåne County, Sweden

Location

Gävle EMS

Gävle, Sweden

Location

Uppsala EMS

Uppsala, Sweden

Location

Västerås EMS

Västerås, Sweden

Location

NHS, South Western Ambulance Service Trust (SWAST)

Bournemouth, Poole & Dorchester, Dorset, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 26247144DERIVED

  • 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.

    PMID: 24240611DERIVED

  • 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.

    PMID: 23351178DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2008

First Posted

February 7, 2008

Study Start

January 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 5, 2012

Record last verified: 2011-06

Locations

GB(1)NL(1)SE(4)