Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Scand J Trauma Resusc Emerg Med. 2018 Aug 30;26(1):70. doi: 10.1186/s13049-018-0538-6.
Mechanical chest compression devices consistently deliver high-quality chest compressions. Small very low-quality studies suggest mechanical devices may be effective as an alternative to manual chest compressions in the treatment of adult in-hospital cardiac arrest patients. The aim of this feasibility trial is to assess the feasibility of conducting an effectiveness trial in this patient population.
COMPRESS-RCT is a multi-centre parallel group feasibility randomised controlled trial, designed to assess the feasibility of undertaking an effectiveness to compare the effect of mechanical chest compressions with manual chest compressions on 30-day survival following in-hospital cardiac arrest. Over approximately two years, 330 adult patients who sustain an in-hospital cardiac arrest and are in a non-shockable rhythm will be randomised in a 3:1 ratio to receive ongoing treatment with a mechanical chest compression device (LUCAS 2/3, Jolife AB/Stryker, Lund, Sweden) or continued manual chest compressions. It is intended that recruitment will occur on a 24/7 basis by the clinical cardiac arrest team. The primary study outcome is the proportion of eligible participants randomised in the study during site operational recruitment hours. Participants will be enrolled using a model of deferred consent, with consent for follow-up sought from patients or their consultee in those that survive the cardiac arrest event. The trial will have an embedded qualitative study, in which we will conduct semi-structured interviews with hospital staff to explore facilitators and barriers to study recruitment.
The findings of COMPRESS-RCT will provide important information about the deliverability of an effectiveness trial to evaluate the effect on 30-day mortality of routine use of mechanical chest compression devices in adult in-hospital cardiac arrest patients.
ISRCTN38139840 , date of registration 9th January 2017.
机械胸外按压设备能持续提供高质量的胸外按压。一些小型极低质量的研究表明,机械设备可能与手动胸外按压一样有效,可作为成人院内心搏骤停患者的治疗替代方法。本可行性试验的目的是评估在该患者人群中开展有效性试验的可行性。
COMPRESS-RCT 是一项多中心平行组可行性随机对照试验,旨在评估开展一项有效性试验的可行性,以比较机械胸外按压与手动胸外按压对院内心搏骤停后 30 天生存率的影响。在大约两年的时间内,将 330 名发生院内心搏骤停且处于非除颤性节律的成年患者以 3:1 的比例随机分为两组,分别接受持续的机械胸外按压治疗(LUCAS 2/3,Jolife AB/Stryker,Lund,瑞典)或持续的手动胸外按压。计划由临床心搏骤停团队 24/7 进行招募。主要研究结局为在站点运营招募期间随机分组的合格参与者比例。将采用延期同意模式招募参与者,对存活心搏骤停事件的患者或其代理人征求随访同意。该试验将嵌入一项定性研究,我们将对医院工作人员进行半结构化访谈,以探讨研究招募的促进因素和障碍。
COMPRESS-RCT 的结果将提供关于开展有效性试验的可实施性的重要信息,以评估在成人院内心搏骤停患者中常规使用机械胸外按压设备对 30 天死亡率的影响。
ISRCTN38139840,注册日期 2017 年 1 月 9 日。