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

Cardiovascular Diseases Clinical Trial

— LINC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609778
• Other study ID #: Jolife 10-0
• Status: Completed
• Phase: N/A
• First received: January 25, 2008
• Last updated: October 4, 2012
• Start date: January 2008
• Est. completion date: August 2012

Study information

• Verified date: June 2011
• Source: Jolife AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uppsala University and the Regional Ethical Review Board in Uppsala, Sweden:
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• LUCAS
Mechanical chest compression

Other:
• Conventional manual resuscitation method
Manual compression

Locations

Country	Name	City	State
Netherlands	Stichting RAVU EMS	Utrecht
Sweden	Gävle EMS	Gävle
Sweden	Kamber, Skåne	Malmö	Skåne
Sweden	Uppsala EMS	Uppsala
Sweden	Västerås EMS	Västerås
United Kingdom	NHS, South Western Ambulance Service Trust (SWAST)	Bournemouth, Poole & Dorchester	Dorset

Sponsors (2)

Lead Sponsor	Collaborator
Jolife AB	Uppsala University Hospital

Countries where clinical trial is conducted

Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Four hour survival from successful restoration of spontaneous circulation.		Four hours survival	No
Secondary	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	No