Extrait

Background and study aims Cardio-pulmonary resuscitation (CPR) is a first aid technique that can be used if someone’s heart has stopped (cardiac arrest). Chest compression during CPR is hard work and many rescuers fail to achieve the required compression depth and compression rate for longer than 1-2 minutes. Also, compressions are interrupted both for good or bad reasons, possibly with a negative impact on outcome. It is not surprising that mechanical chest compression devices have been developed which could give chest compressions without interruption and without fatigue. There were great expectations that these devices could improve survival from cardiac arrest. Unfortunately, at the time of design of this study, no studies had showed that expected benefit, rather the opposite. Since our current study started, several studies have been published that also failed to show a clear benefit of mechanical chest compression compared to manual compressions. One possible explanation could be that the potential benefit was counteracted by possibly too forceful compressions or by possible incorrect positioning of the device, causing damage to internal organs. Such damage was not demonstrated convincingly, only in some anecdotal cases. The purpose of our study is to specifically look for damage to bone structures and internal organs by means of postmortem CT scans, autopsy, or evaluation of the clinical course of the patient after successful resuscitation. All analyses are done by observers that are ‘blind’, i.e. not aware of the method of chest compression that was used in a particular patient. There are several different ways to administer chest compressions and to achieve the desired propelling of blood. One of the ways is a device that rhythmically applies force to a band over the chest, causing a more general compression of the whole chest, rather than only pushing the sternum (breastbone) inward. This device, Autopulse, is subject of this study and is compared to manual chest compression by in-hospital rescuers. Who can participate? Patients aged 18 years or over, either sex, are included in the study when in cardiac arrest and requiring full CPR, which is ongoing when the resuscitation team arrives with the study device. What does the study involve? When the need for CPR arises in a patient, chest compressions are performed with either the Autopulse or with conventional manual chest compressions. The method used is chosen at random. If the patient does not survive, the family is approached for permission to perform a postmortem CT scan (which does not open the body but only involves an X-ray study of the intact body) or an autopsy. As the patient is unconscious from the outset of cardiac arrest, the patient is not aware of the use of either devices. What are the possible benefits and risks of participating? The benefit could be that more patients survive and no excess damage is done. The risk could be that the excess damage is demonstrated. As these devices are commercially available and applied widely, understanding the possible risks of its use is of great importance. Where is the study run from? Academic Medical Centre (AMC) (Netherlands). When is the study starting and how long is it expected to run for? The study ran from June 2009 to May 2014. Who is funding the study? Zoll Medical Corporation (USA) and AMC Medical Research BV (Netherlands). Who is the main contact? Dr Rudolph Koster

Critère d'inclusion

• Circulatory arrest

Liens

• isrctn
• ictrp