A Comparison of Conventional Adult Out-of-hospital Cardiopulmonary Resuscitation Against a Concept With Mechanical Chest Compressions and Simultaneous Defibrillation - LINC Study
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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 |
- Four hour survival from successful restoration of spontaneous circulation. [ Time Frame: Four hours survival ] [ Designated as safety issue: No ]
- 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 |
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| 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 | |
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 May 23, 2013