Abstract
BackgroundDespite 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.MethodsThe 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.DiscussionEarly 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.Trial registrationThis study is listed on the ISRCTN registry with study ID ISRCTN16601772.
Highlights
Despite medical advances, major surgery remains high risk
Early detection and treatment of complications minimises the need for critical care, improves patient outcomes, and produces significant cost savings for the healthcare system
Patients having major surgery are at high risk of complications, some of which can be life-threatening
Summary
Study setting All participants will be recruited from St James’s University Hospital, Leeds, UK. Information on the ideal method of randomisation, which will include calculation of intra-cluster correlation co-efficient to investigate whether there is any inherent clustering in outcomes based on which ward bay a participant is admitted to Adherence to protocol, and reasons for nonadherence, as defined by the number of patients who do not receive the correct type of monitoring as per randomisation (and reasons for this) and the number of patients who do not wear the patch for their entire hospital stay or at least 5 days during their admission. Patients’ participation in the trial will end when they are discharged from hospital At this point, remotely monitored patients will be invited to complete a questionnaire regarding their experiences of wearing the patch (see Appendix 1). Dissemination The trial results will be disseminated in a published manuscript and through presentation to clinical and patient and public forums with the aim of reaching healthcare workers and other stakeholders throughout the healthcare system
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