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.
BACKGROUND
The LUCAS™ device delivers mechanical chest compressions that have been shown in experimental studies to improve perfusion pressures to the brain and heart as well as augmenting cerebral blood flow and end tidal CO2, compared with results from standard manual cardiopulmonary resuscitation (CPR). Two randomised pilot studies in out-of-hospital cardiac arrest patients have not shown improved outcome when compared with manual CPR. There remains evidence from small case series that the device can be potentially beneficial compared with manual chest compressions in specific situations. This multicentre study is designed to evaluate the efficacy and safety of mechanical chest compressions with the LUCAS™ device whilst allowing defibrillation during on-going CPR, and comparing the results with those of conventional resuscitation.


METHODS
This article describes the design and protocol of the LINC-study which is a randomised controlled multicentre study of 2500 out-of-hospital cardiac arrest patients. The study has been registered at ClinicalTrials.gov (http://clinicaltrials.gov/ct2/show/NCT00609778?term=LINC&rank=1).


RESULTS
Primary endpoint is four-hour survival after successful restoration of spontaneous circulation. The safety aspect is being evaluated by post mortem examinations in 300 patients that may reflect injuries from CPR.


CONCLUSIONS
This large multicentre study will contribute to the evaluation of mechanical chest compression in CPR and specifically to the efficacy and safety of the LUCAS™ device when used in association with defibrillation during on-going CPR.
Department of Surgical Sciences/Anaesthesiology & Intensive Care, Uppsala University, Uppsala, Sweden. sten.rubertsson@akademiska.se
Sten
S
Rubertsson
Johan
J
Silfverstolpe
Liselott
L
Rehn
Thomas
T
Nyman
Rob
R
Lichtveld
Rene
R
Boomars
Wendy
W
Bruins
Björn
B
Ahlstedt
Helena
H
Puggioli
Erik
E
Lindgren
David
D
Smekal
Gunnar
G
Skoog
Robert
R
Kastberg
Anna
A
Lindblad
David
D
Halliwell
Martyn
M
Box
Fredrik
F
Arnwald
Bjarne Madsen
BM
Hardig
Douglas
D
Chamberlain
Johan
J
Herlitz
Rolf
R
Karlsten
D000328:Adult; D000465:Algorithms; D016887:Cardiopulmonary Resuscitation / Q000295:instrumentation*; D002985:Clinical Protocols; D004554:Electric Countershock; D006336:Heart Massage / Q000295:instrumentation*; D006801:Humans; D058687:Out-of-Hospital Cardiac Arrest / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D015996:Survival Rate; D016896:Treatment Outcome