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Reliability of a wearable wireless patch for continuous remote monitoring of vital signs in patients recovering from major surgery: a clinical validation study from the TRaCINg trial.

ABSTRACT: OBJECTIVE:To validate whether a wearable remote vital signs monitor could accurately measure heart rate (HR), respiratory rate (RR) and temperature in a postsurgical patient population at high risk of complications. DESIGN:Manually recorded vital signs data were paired with vital signs data derived from the remote monitor set in patients participating in the Trial of Remote versus Continuous INtermittent monitoring (TRaCINg) study: a trial of continuous remote vital signs monitoring. SETTING:St James's University Hospital, UK. PARTICIPANTS:51 patients who had undergone major elective general surgery. INTERVENTIONS:The intervention was the SensiumVitals monitoring system. This is a wireless patch worn on the patient's chest that measures HR, RR and temperature continuously. The reference standard was nurse-measured manually recorded vital signs. PRIMARY AND SECONDARY OUTCOME MEASURES:The primary outcomes were the 95% limits of agreement between manually recorded and wearable patch vital sign recordings of HR, RR and temperature. The secondary outcomes were the percentage completeness of vital sign patch data for each vital sign. RESULTS:1135 nurse observations were available for analysis. There was no clinically meaningful bias in HR (1.85 bpm), but precision was poor (95% limits of agreement -23.92 to 20.22 bpm). Agreement was poor for RR (bias 2.93 breaths per minute, 95% limits of agreement -8.19 to 14.05 breaths per minute) and temperature (bias 0.82°C, 95% limits of agreement -1.13°C to 2.78°C). Vital sign patch data completeness was 72.8% for temperature, 59.2% for HR and 34.1% for RR. Distributions of RR in manually recorded measurements were clinically implausible. CONCLUSIONS:The continuous monitoring system did not reliably provide HR consistent with nurse measurements. The accuracy of RR and temperature was outside of acceptable limits. Limitations of the system could potentially be overcome through better signal processing. While acknowledging the time pressures placed on nursing staff, inaccuracies in the manually recorded data present an opportunity to increase awareness about the importance of manual observations, particularly with regard to methods of manual HR and RR measurements.

SUBMITTER: Downey C

PROVIDER: S-EPMC6701670 | biostudies-other | 2019 Aug

REPOSITORIES: biostudies-other

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Reliability of a wearable wireless patch for continuous remote monitoring of vital signs in patients recovering from major surgery: a clinical validation study from the TRaCINg trial.

Downey Candice C Ng Shu S Jayne David D Wong David D

BMJ open 20190815 8

<h4>Objective</h4>To validate whether a wearable remote vital signs monitor could accurately measure heart rate (HR), respiratory rate (RR) and temperature in a postsurgical patient population at high risk of complications.<h4>Design</h4>Manually recorded vital signs data were paired with vital signs data derived from the remote monitor set in patients participating in the Trial of Remote versus Continuous INtermittent monitoring (TRaCINg) study: a trial of continuous remote vital signs monitori ...[more]

PMID: 31420399

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Project description:BACKGROUND:Vital signs monitoring is a universal tool for the detection of postoperative complications; however, unwell patients can be missed between traditional observation rounds. New remote monitoring technologies promise to convey the benefits of continuous monitoring to patients in general wards. OBJECTIVE:The aim of this pilot study was to evaluate whether continuous remote vital signs monitoring is a practical and acceptable way of monitoring surgical patients and to optimize the delivery of a definitive trial. METHODS:We performed a prospective, cluster-randomized, parallel-group, unblinded, controlled pilot study. Patients admitted to 2 surgical wards at a large tertiary hospital received either continuous and intermittent vital signs monitoring or intermittent monitoring alone using an early warning score system. Continuous monitoring was provided by a wireless patch, worn on the patient's chest, with data transmitted wirelessly every 2 minutes to a central monitoring station or a mobile device carried by the patient's nurse. The primary outcome measure was time to administration of antibiotics in sepsis. The secondary outcome measures included the length of hospital stay, 30-day readmission rate, mortality, and patient acceptability. RESULTS:Overall, 226 patients were randomized between January and June 2017. Of 226 patients, 140 were randomized to continuous remote monitoring and 86 to intermittent monitoring alone. On average, patients receiving continuous monitoring were administered antibiotics faster after evidence of sepsis (626 minutes, n=22, 95% CI 431.7-820.3 minutes vs 1012.8 minutes, n=12, 95% CI 425.0-1600.6 minutes), had a shorter average length of hospital stay (13.3 days, 95% CI 11.3-15.3 days vs 14.6 days, 95% CI 11.5-17.7 days), and were less likely to require readmission within 30 days of discharge (11.4%, 95% CI 6.16-16.7 vs 20.9%, 95% CI 12.3-29.5). Wide CIs suggest these differences are not statistically significant. Patients found the monitoring device to be acceptable in terms of comfort and perceived an enhanced sense of safety, despite 24% discontinuing the intervention early. CONCLUSIONS:Remote continuous vital signs monitoring on surgical wards is practical and acceptable to patients. Large, well-controlled studies in high-risk populations are required to determine whether the observed trends translate into a significant benefit for continuous over intermittent monitoring. TRIAL REGISTRATION:International Standard Randomised Controlled Trial Number ISRCTN60999823; http://www.isrctn.com /ISRCTN60999823 (Archived by WebCite at http://www.webcitation.org/73ikP6OQz).

Project description:BACKGROUND:Continuous monitoring of vital signs by using wearable wireless devices may allow for timely detection of clinical deterioration in patients in general wards in comparison to detection by standard intermittent vital signs measurements. A large number of studies on many different wearable devices have been reported in recent years, but a systematic review is not yet available to date. OBJECTIVE:The aim of this study was to provide a systematic review for health care professionals regarding the current evidence about the validation, feasibility, clinical outcomes, and costs of wearable wireless devices for continuous monitoring of vital signs. METHODS:A systematic and comprehensive search was performed using PubMed/MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials from January 2009 to September 2019 for studies that evaluated wearable wireless devices for continuous monitoring of vital signs in adults. Outcomes were structured by validation, feasibility, clinical outcomes, and costs. Risk of bias was determined by using the Mixed Methods Appraisal Tool, quality assessment of diagnostic accuracy studies 2nd edition, or quality of health economic studies tool. RESULTS:In this review, 27 studies evaluating 13 different wearable wireless devices were included. These studies predominantly evaluated the validation or the feasibility outcomes of these devices. Only a few studies reported the clinical outcomes with these devices and they did not report a significantly better clinical outcome than the standard tools used for measuring vital signs. Cost outcomes were not reported in any study. The quality of the included studies was predominantly rated as low or moderate. CONCLUSIONS:Wearable wireless continuous monitoring devices are mostly still in the clinical validation and feasibility testing phases. To date, there are no high quality large well-controlled studies of wearable wireless devices available that show a significant clinical benefit or cost-effectiveness. Such studies are needed to help health care professionals and administrators in their decision making regarding implementation of these devices on a large scale in clinical practice or in-home monitoring.

Project description:BackgroundWearable devices can be used for continuous patient monitoring in the general ward, increasing patient safety. Little is known about the experiences and expectations of patients and health care professionals regarding continuous monitoring with these devices.ObjectiveThis study aimed to identify positive and negative effects as well as barriers and facilitators for the use of two wearable devices: ViSi Mobile (VM) and HealthPatch (HP).MethodsIn this randomized controlled trial, 90 patients admitted to the internal medicine and surgical wards of a university hospital in the Netherlands were randomly assigned to continuous vital sign monitoring using VM or HP and a control group. Users' experiences and expectations were addressed using semistructured interviews. Nurses, physician assistants, and medical doctors were also interviewed. Interviews were analyzed using thematic content analysis. Psychological distress was assessed using the State Trait Anxiety Inventory and the Pain Catastrophizing Scale. The System Usability Scale was used to assess the usability of both devices.ResultsA total of 60 patients, 20 nurses, 3 physician assistants, and 6 medical doctors were interviewed. We identified 47 positive and 30 negative effects and 19 facilitators and 36 barriers for the use of VM and HP. Frequently mentioned topics included earlier identification of clinical deterioration, increased feelings of safety, and VM lines and electrodes. No differences related to psychological distress and usability were found between randomization groups or devices.ConclusionsBoth devices were well received by most patients and health care professionals, and the majority of them encouraged the idea of monitoring vital signs continuously in the general ward. This comprehensive overview of barriers and facilitators of using wireless devices may serve as a guide for future researchers, developers, and health care institutions that consider implementing continuous monitoring in the ward.Trial registrationClinicaltrials.gov NCT02933307; http://clinicaltrials.gov/ct2/show/NCT02933307.

Project description:BackgroundNeurocognitive testing is an important concussion evaluation tool, but for neurocognitive tests to be useful, their psychometric properties must be well established. Test-retest reliability of computerized neurocognitive tests can influence their clinical utility. The reliability for a commonly used computerized neurocognitive test, CNS Vital Signs, is not well established. The purpose of this study was to examine test-retest reliability and reliable change indices for CNS Vital Signs in a healthy, physically active college population.HypothesisCNS Vital Signs yields acceptable test-retest reliability, with greater reliability between the second and third test administration compared with between the first and second administration.Study designCohort study.Level of evidenceLevel 3.MethodsForty healthy, active volunteers (16 men, 24 women; mean age, 21.05 ± 2.17 years) reported to a clinical laboratory for 3 sessions, 1 week apart. At each session, participants were administered CNS Vital Signs. Outcomes included standard scores for the following CNS Vital Signs domains: verbal memory, visual memory, psychomotor speed, cognitive flexibility, complex attention, processing speed, reaction time, executive functioning, and reasoning.ResultsParticipants performed significantly better on the second session and/or third session than they did on the first testing session on 6 of 9 neurocognitive domains. Pearson r test-retest correlations between sessions ranged from 0.11 to 0.87. Intraclass correlation coefficients ranged from 0.10 to 0.86.ConclusionClinicians should consider using reliable change indices to account for practice effects, identify meaningful score changes due to pathology, and inform clinical decisions.Clinical relevanceThis study highlights the importance of clinicians understanding the psychometric properties of computerized neurocognitive tests when using them in the management of sport-related concussion. If CNS Vital Signs is administered twice within a small time frame (such as 1 week), athletes should be expected to improve between the first and second administration.

Project description:BACKGROUND AND OBJECTIVES:Intermittent vital signs measurements are the current standard on hospital wards, typically recorded once every 8?hours. Early signs of deterioration may therefore be missed. Recent innovations have resulted in 'wearable' sensors, which may capture patient deterioration at an earlier stage. The objective of this study was to determine whether a wireless 'patch' sensor is able to reliably measure respiratory and heart rate continuously in high-risk surgical patients. The secondary objective was to explore the potential of the wireless sensor to serve as a safety monitor. DESIGN:In an observational methods comparisons study, patients were measured with both the wireless sensor and bedside routine standard for at least 24?hours. SETTING:University teaching hospital, single centre. PARTICIPANTS:Twenty-five postoperative surgical patients admitted to a step-down unit. OUTCOME MEASURES:Primary outcome measures were limits of agreement and bias of heart rate and respiratory rate. Secondary outcome measures were sensor reliability, defined as time until first occurrence of data loss. RESULTS:1568?hours of vital signs data were analysed. Bias and 95% limits of agreement for heart rate were -1.1 (-8.8 to 6.5) beats per minute. For respiration rate, bias was -2.3 breaths per minute with wide limits of agreement (-15.8 to 11.2 breaths per minute). Median filtering over a 15 min period improved limits of agreement of both respiration and heart rate. 63% of the measurements were performed without data loss greater than 2?min. Overall data loss was limited (6% of time). CONCLUSIONS:The wireless sensor is capable of accurately measuring heart rate, but accuracy for respiratory rate was outside acceptable limits. Remote monitoring has the potential to contribute to early recognition of physiological decline in high-risk patients. Future studies should focus on the ability to detect patient deterioration on low care environments and at home after discharge.

Dataset Information

Reliability of a wearable wireless patch for continuous remote monitoring of vital signs in patients recovering from major surgery: a clinical validation study from the TRaCINg trial.

Publications

Reliability of a wearable wireless patch for continuous remote monitoring of vital signs in patients recovering from major surgery: a clinical validation study from the TRaCINg trial.

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