Downey, CL orcid.org/0000-0001-9818-8002, Croft, J orcid.org/0000-0001-7586-3394, Buckley, H et al. (3 more authors) (2018) Trial of Remote Continuous versus Intermittent NEWS monitoring after major surgery (TRaCINg): protocol for a feasibility randomised controlled trial. Pilot and Feasibility Studies, 4 (1). 112. ISSN 2055-5784
Abstract
Background: 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.
Methods: 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.
Discussion: 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.
Trial registration: This study is listed on the ISRCTN registry with study ID ISRCTN16601772.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | (c) The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
Keywords: | Continuous, Early warning score, Vital signs, Monitoring, Surgery, Complications |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Inst of Biomed & Clin Sciences (LIBACS) (Leeds) > Trans Anaesthetics & Surgical Sciences (Leeds) |
Funding Information: | Funder Grant number NIHR National Inst Health Research drf-2016-09-037 |
Depositing User: | Symplectic Publications |
Date Deposited: | 21 Jun 2018 10:59 |
Last Modified: | 21 Jun 2018 10:59 |
Status: | Published |
Publisher: | BioMed Central |
Identification Number: | 10.1186/s40814-018-0299-z |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:132366 |