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
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Device: LUCAS
Other: Conventional manual resuscitation method

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Comparison of Conventional Adult Out-of-hospital Cardiopulmonary Resuscitation Against a Concept With Mechanical Chest Compressions and Simultaneous Defibrillation

Resource links provided by NLM:


Further study details as provided by Jolife AB:

Primary Outcome Measures:
  • Four hour survival from successful restoration of spontaneous circulation. [ Time Frame: Four hours survival ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2500
Study Start Date: January 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609778

Locations
Netherlands
Stichting RAVU EMS
Utrecht, Netherlands
Sweden
Kamber, Skåne
Malmö, Skåne, Sweden
Gävle EMS
Gävle, Sweden
Uppsala EMS
Uppsala, Sweden
Västerås EMS
Västerås, Sweden
United Kingdom
NHS, South Western Ambulance Service Trust (SWAST)
Bournemouth, Poole & Dorchester, Dorset, United Kingdom
Sponsors and Collaborators
Jolife AB
Uppsala University Hospital
  More Information

No publications provided by Jolife AB

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jolife AB
ClinicalTrials.gov Identifier: NCT00609778     History of Changes
Other Study ID Numbers: Jolife 10-0
Study First Received: January 25, 2008
Last Updated: October 4, 2012
Health Authority: Uppsala University and the Regional Ethical Review Board in Uppsala, Sweden:

Keywords provided by Jolife AB:
CPR
Mechanical
Manual
Survival
ROSC

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014