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

This study has been completed.
Sponsor:
Collaborator:
Uppsala University Hospital
Information provided by (Responsible Party):
Jolife AB
ClinicalTrials.gov Identifier:
NCT00609778
First received: January 25, 2008
Last updated: October 4, 2012
Last verified: June 2011

January 25, 2008
October 4, 2012
January 2008
August 2012   (final data collection date for primary outcome measure)
Four hour survival from successful restoration of spontaneous circulation. [ Time Frame: Four hours survival ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00609778 on ClinicalTrials.gov Archive Site
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). [ Time Frame: 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Comparison of Conventional Adult Out-of-hospital Cardiopulmonary Resuscitation Against a Concept With Mechanical Chest Compressions and Simultaneous Defibrillation - LINC Study
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Cardiovascular Diseases
  • Device: LUCAS
    Mechanical chest compression
  • Other: Conventional manual resuscitation method
    Manual compression
  • Experimental: 1:Mechanical CPR with LUCAS
    A Mechanical device that provides chest compressions
    Intervention: Device: LUCAS
  • Active Comparator: 2 Manual CPR
    Manual chest compressions
    Intervention: Other: Conventional manual resuscitation method

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2500
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   Sweden,   United Kingdom
 
NCT00609778
Jolife 10-0
Yes
Jolife AB
Jolife AB
Uppsala University Hospital
Not Provided
Jolife AB
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP