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

Sten Rubertsson, Johan Silfverstolpe, Liselott Rehn, Thomas Nyman, Rob Lichtveld, Rene Boomars, Wendy Bruins, Björn Ahlstedt, Helena Puggioli, Erik Lindgren, David Smekal, Gunnar Skoog, Robert Kastberg, Anna Lindblad, David Halliwell, Martyn Box, Fredrik Arnwald, Bjarne Madsen Hardig, Douglas Chamberlain, Johan Herlitz, Rolf Karlsten, Sten Rubertsson, Johan Silfverstolpe, Liselott Rehn, Thomas Nyman, Rob Lichtveld, Rene Boomars, Wendy Bruins, Björn Ahlstedt, Helena Puggioli, Erik Lindgren, David Smekal, Gunnar Skoog, Robert Kastberg, Anna Lindblad, David Halliwell, Martyn Box, Fredrik Arnwald, Bjarne Madsen Hardig, Douglas Chamberlain, Johan Herlitz, Rolf Karlsten

Abstract

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/design: 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 (https://ichgcp.net/clinical-trials-registry/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.

Conclusion: 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.

Figures

Figure 1
Figure 1
The separate algorithm used for patients suffering a cardiac arrest witnessed by the ambulance crew and used for these witnessed cases for eligible judgment and randomisation into the LINC-study.
Figure 2
Figure 2
The LUCAS algorithm used in the LINC-study.
Figure 3
Figure 3
The adult ALS algorithm used as control in the LINC-study.

References

    1. Steen S, Liao Q, Pierre L, Paskevicius A, Sjoberg T. Evaluation of LUCAS, a new device for automatic mechanical compression and active decompression resuscitation. Resuscitation. 2002;55:285–299. doi: 10.1016/S0300-9572(02)00271-X.
    1. Rubertsson S, Karlsten R. Increased cortical cerebral blood flow with LUCAS; a new device for mechanical chest compressions compared to standard external compressions during experimental cardiopulmonary resuscitation. Resuscitation. 2005;65:357–363. doi: 10.1016/j.resuscitation.2004.12.006.
    1. Axelsson C, Karlsson T, Axelsson AB, Herlitz J. Mechanical active compression-decompression cardiopulmonary resuscitation (ACD-CPR) versus manual CPR according to pressure of end tidal carbon dioxide (P(ET)CO2) during CPR in out-of-hospital cardiac arrest (OHCA) Resuscitation. 2009;80:1099–1103. doi: 10.1016/j.resuscitation.2009.08.006.
    1. Wyss CA, Fox J, Franzeck F. et al.Mechanical versus manual chest compression during CPR in a cardiac catherisation setting. Cardivascular Med. 2010;12:92–96.
    1. Wagner H, Madsen Hardig B, Harnek J, Gotberg M, Olivecrona G. Aspects on resuscitation in the coronary interventional catheter laboratory [abstract] Circulation. 2010;23:A91.
    1. Wagner H, Terkelsen CJ, Friberg H. et al.Cardiac arrest in the catheterisation laboratory: a 5-year experience of using mechanical chest compressions to facilitate PCI during prolonged resuscitation efforts. Resuscitation. 2010;81:383–387. doi: 10.1016/j.resuscitation.2009.11.006.
    1. Bonnemeier H, Simonis G, Olivecrona G. et al.Continuous mechanical chest compression during in-hospital cardiopulmonary resuscitation of patients with pulseless electrical activity. Resuscitation. 2011;82:155–159. doi: 10.1016/j.resuscitation.2010.10.019.
    1. Friberg H, Rundgren M. Submersion, accidental hypothermia and cardiac arrest, mechanical chest compressions as a bridge to final treatment: a case report. Scand J Trauma Resusc Emerg Med. 2009;17:7. doi: 10.1186/1757-7241-17-7.
    1. Gottignies P, Devriendt J, Tran Ngoc E. et al.Thrombolysis associated with LUCAS (Lund University Cardiopulmonary Assist System) as treatment of valve thrombosis resulting in cardiac arrest. Am J Emerg Med. 2010;29:476. e3–476.e5.
    1. Grogaard HK, Wik L, Eriksen M, Brekke M, Sunde K. Continuous mechanical chest compressions during cardiac arrest to facilitate restoration of coronary circulation with percutaneous coronary intervention. J Am Coll Cardiol. 2007;50:1093–1094. doi: 10.1016/j.jacc.2007.05.028.
    1. Holmstrom P, Boyd J, Sorsa M, Kuisma M. A case of hypothermic cardiac arrest treated with an external chest compression device (LUCAS) during transport to re-warming. Resuscitation. 2005;67:139–141. doi: 10.1016/j.resuscitation.2005.04.013.
    1. Wik L, Kiil S. Use of an automatic mechanical chest compression device (LUCAS) as a bridge to establishing cardiopulmonary bypass for a patient with hypothermic cardiac arrest. Resuscitation. 2005;66:391–394. doi: 10.1016/j.resuscitation.2005.03.011.
    1. Nolan JP, Deakin CD, Soar J, Bottiger BW, Smith G. European Resuscitation Council guidelines for resuscitation 2005. Section 4. Adult advanced life support. Resuscitation. 2005;67:S39–S86.
    1. Handley AJ, Koster R, Monsieurs K, Perkins GD, Davies S, Bossaert L. European Resuscitation Council guidelines for resuscitation 2005. Section 2. Adult basic life support and use of automated external defibrillators. Resuscitation. 2005;67:S7–S23.
    1. Axelsson C, Nestin J, Svensson L, Axelsson AB, Herlitz J. Clinical consequences of the introduction of mechanical chest compression in the EMS system for treatment of out-of-hospital cardiac arrest-a pilot study. Resuscitation. 2006;71:47–55. doi: 10.1016/j.resuscitation.2006.02.011.
    1. Smekal D, Johansson J, Huzevka T, Rubertsson S. A pilot study of mechanical chest compressions with the LUCAS device in cardiopulmonary resuscitation. Resuscitation. 2011;82:702–706. doi: 10.1016/j.resuscitation.2011.01.032.
    1. LUCAS™ 1 Chest Compression System, Instructions for Use. .
    1. LUCAS™ 2 Chest Compression System, Instructions for Use. .
    1. Nationella registret för hjärtstopp utanför sjukhus, Årsrapport 2007. .
    1. O’Brien PC, Fleming TR. et al.A multiple testing procedure for clinical trials. Biometrics. 1979;35:549–556. doi: 10.2307/2530245.
    1. Cheskes S, Schmicker RH, Christenson J. et al.Perishock pause: an independent predictor of survival from out-of-hospital shockable cardiac arrest. Circulation. 2011;124:58–66. doi: 10.1161/CIRCULATIONAHA.110.010736.
    1. Lerner EB, Persse D, Souders CM. et al.Design of the Circulation Improving Resuscitation Care (CIRC) Trial: a new state of the art design for out-of-hospital cardiac arrest research. Resuscitation. 2011;82:294–299. doi: 10.1016/j.resuscitation.2010.11.013.
    1. Perkins GD, Woollard M, Cooke MW. et al.Prehospital randomised assessment of a mechanical compression device in cardiac arrest (PaRAMeDIC) trial protocol. Scand J Trauma Resusc Emerg Med. 2010;18:58. doi: 10.1186/1757-7241-18-58.
    1. Hallstrom A, Rea TD, Sayre MR. et al.Manual chest compression vs use of an automated chest compression device during resuscitation following out-of-hospital cardiac arrest: a randomized trial. JAMA. 2006;295:2620–2628. doi: 10.1001/jama.295.22.2620.
    1. Baubin M, Rabl W. How to detect side effects of chest compressions? Resuscitation. 2011;82:1262. doi: 10.1016/j.resuscitation.2011.08.001.
    1. Smekal D, Johansson J, Huzevka T, Rubertsson S. No difference in autopsy detected injuries in cardiac arrest patients treated with manual chest compressions compared with mechanical compressions with the LUCAS device–a pilot study. Resuscitation. 2009;80:1104–1107. doi: 10.1016/j.resuscitation.2009.06.010.
    1. Menzies D, Barton D, Nolan N. Does the LUCAS device result in increased injury during CPR? [abstract] Resuscitation. 2010;81S:S1–S114.

Source: PubMed

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