Downey C L, Croft J, Buckley H, Randell R, Brown J M, Jayne D G
Leeds Institute of Biomedical and Clinical Sciences, Clinical Sciences Building, St. James's University Hospital, University of Leeds, Level 7 Clinical Sciences Building, Leeds, LS9 7TF UK.
2Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9NL UK.
Pilot Feasibility Stud. 2018 Jun 11;4:112. doi: 10.1186/s40814-018-0299-z. eCollection 2018.
Despite medical advances, major surgery remains high risk. Up to 44% of patients experience postoperative complications, which can have huge impacts for patients and the healthcare system. Early recognition of postoperative complications is crucial in reducing morbidity and preventing long-term disability. The current standard of care is intermittent manual vital signs monitoring, but new wearable remote monitors offer the benefits of continuous vital signs monitoring without limiting the patient's mobility. The aim of this study is to evaluate the feasibility, acceptability and clinical impacts of continuous remote monitoring after major surgery.
The study is a randomised, controlled, unblinded, parallel group, feasibility trial. Adult patients undergoing elective major surgery will be invited to participate if they have the capacity to provided informed, written consent and do not have a cardiac pacemaker or an allergy to adhesives. Participants will be randomly assigned to receive continuous remote monitoring and normal National Early Warning Score (NEWS) monitoring (intervention group) or normal NEWS monitoring alone (control group). Continuous remote monitoring will be achieved using the SensiumVitals® wireless patch which is worn on the patient's chest and monitors heart rate, respiratory rate and temperature continuously and alerts the nurse when there is deviation from pre-set physiological norms. Participants will be followed up throughout their hospital admission and for 30 days after discharge. Feasibility will be assessed by evaluating recruitment rate, adherence to protocol and randomisation, and the amount of missing data. The acceptability of the patch to nursing staff and patients will be assessed using questionnaires and interviews. Clinical outcomes will include time to antibiotics in cases of sepsis, length of hospital stay, number of critical care admissions and rate of readmission within 30 days of discharge.
Early detection and treatment of complications minimises the need for critical care, improves patient outcomes, and produces significant cost savings for the healthcare system. Remote continuous monitoring systems have the potential to allow earlier detection of complications, but evidence from the literature is mixed. Demonstrating significant benefit over intermittent monitoring to offset the practical and economic implications of continuous monitoring requires well-controlled studies in high-risk populations to demonstrate significant differences in clinical outcomes; this feasibility trial seeks to provide evidence of how best to conduct such a confirmatory trial.
This study is listed on the ISRCTN registry with study ID ISRCTN16601772.
尽管医学不断进步，但大手术仍然具有高风险。高达44%的患者会出现术后并发症，这可能对患者和医疗系统产生巨大影响。早期识别术后并发症对于降低发病率和预防长期残疾至关重要。当前的护理标准是间歇性手动生命体征监测，但新型可穿戴远程监测设备提供了连续生命体征监测的优势，且不限制患者的活动能力。本研究的目的是评估大手术后连续远程监测的可行性、可接受性及临床影响。
本研究为一项随机、对照、非盲、平行组可行性试验。如果成年择期大手术患者有能力提供知情书面同意书，且没有心脏起搏器或对粘合剂过敏，将被邀请参与。参与者将被随机分配接受连续远程监测和常规国家早期预警评分（NEWS）监测（干预组）或仅接受常规NEWS监测（对照组）。连续远程监测将使用佩戴在患者胸部的SensiumVitals®无线贴片实现，该贴片可连续监测心率、呼吸频率和体温，并在出现偏离预设生理规范的情况时向护士发出警报。参与者将在整个住院期间及出院后30天接受随访。可行性将通过评估招募率、对方案的依从性和随机化情况以及缺失数据量来评估。贴片对护理人员和患者的可接受性将通过问卷调查和访谈进行评估。临床结果将包括脓毒症病例中使用抗生素的时间、住院时间、重症监护病房收治次数以及出院后30天内的再入院率。
并发症的早期检测和治疗可将重症监护需求降至最低，改善患者预后，并为医疗系统节省大量成本。远程连续监测系统有可能实现并发症的更早检测，但文献中的证据参差不齐。要证明相对于间歇性监测有显著益处，以抵消连续监测的实际和经济影响，需要在高危人群中进行严格对照研究，以证明临床结果存在显著差异；这项可行性试验旨在提供关于如何最好地开展此类验证性试验的证据。
本研究已在国际标准随机对照试验编号注册库（ISRCTN）注册，研究编号为ISRCTN16601772。
