世界各地的医院都实施了基于生命体征的跟踪和触发系统(TTS),以识别临床恶化的患者。TTS可以提供预后信息,但不积极包括临床评估,其对严重不良事件的影响仍不确定.对未来的需求,证明TTS有效性的多中心研究在过去十年中不断发展。个体早期预警评分(I-EWS)是一种新开发的TTS,具有基于生命体征的汇总评分,可以根据患者的临床评估进行调整。目的是将I-EWS与现有的国家早期预警评分(NEWS)算法在临床结果和资源使用方面进行比较。
在未来,多中心,集群随机化,交叉,非自卑研究。八家医院被随机分配使用新闻与丹麦首都地区新闻覆盖系统(CROS)或实施I-EWS6.5个月,然后是交叉。根据他们的临床评估,护理人员可以调整总分,最高为-4或+6分。我们预计将包括150000名独特的患者。主要终点是30天的全因死亡率。共同终点是患者每天新闻/I-EWS评分的平均次数,次要结局是48小时和7天的全因死亡率以及住院时间.
该研究提交给区域伦理委员会,该委员会决定根据丹麦法律不需要正式批准(J.不。1701733).I-EWS研究是一个很大的前瞻性,随机多中心研究,调查在TTS中整合护理人员进行的临床评估的效果,在与国际上使用的新闻的正面比较中,有机会使用CROS。
NCT03690128。
Track and trigger systems (TTSs) based on vital signs are implemented in hospitals worldwide to identify patients with clinical deterioration. TTSs may provide prognostic information but do not actively include clinical assessment, and their impact on severe adverse events remain uncertain. The demand for prospective, multicentre studies to demonstrate the effectiveness of TTSs has grown the last decade. Individual Early Warning Score (I-EWS) is a newly developed TTS with an aggregated score based on vital signs that can be adjusted according to the clinical assessment of the patient. The objective is to compare I-EWS with the existing National Early Warning Score (NEWS) algorithm regarding clinical outcomes and use of resources.
In a prospective, multicentre, cluster-randomised, crossover, non-inferiority study. Eight hospitals are randomised to use either NEWS in combination with the Capital Region of Denmark NEWS Override System (CROS) or implement I-EWS for 6.5 months, followed by a crossover. Based on their clinical assessment, the nursing staff can adjust the aggregated score with a maximum of -4 or +6 points. We expect to include 150 000 unique patients. The primary endpoint is all-cause mortality at 30 days. Coprimary endpoint is the average number of times per day a patient is NEWS/I-EWS-scored, and secondary outcomes are all-cause mortality at 48 hours and at 7 days as well as length of stay.
The study was presented for the Regional Ethics committee who decided that no formal approval was needed according to Danish law (J.no. 1701733). The I-EWS study is a large prospective, randomised multicentre study that investigates the effect of integrating a clinical assessment performed by the nursing staff in a TTS, in a head-to-head comparison with the internationally used NEWS with the opportunity to use CROS.
NCT03690128.