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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:BackgroundVital 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.ObjectiveThe 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.MethodsWe 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.ResultsOverall, 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.ConclusionsRemote 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 registrationInternational 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:BackgroundContinuous monitoring of vital signs (CMVS) using wearable wireless sensors is increasingly available to patients in general wards and can improve outcomes and reduce nurse workload. To assess the potential impact of such systems, successful implementation is important. We developed a CMVS intervention and implementation strategy and evaluated its success in 2 general wards.ObjectiveWe aimed to assess and compare intervention fidelity in 2 wards (internal medicine and general surgery) of a large teaching hospital.MethodsA mixed methods sequential explanatory design was used. After thorough training and preparation, CMVS was implemented-in parallel with the standard intermittent manual measurements-and executed for 6 months in each ward. Heart rate and respiratory rate were measured using a chest-worn wearable sensor, and vital sign trends were visualized on a digital platform. Trends were routinely assessed and reported each nursing shift without automated alarms. The primary outcome was intervention fidelity, defined as the proportion of written reports and related nurse activities in case of deviating trends comparing early (months 1-2), mid- (months 3-4), and late (months 5-6) implementation periods. Explanatory interviews with nurses were conducted.ResultsThe implementation strategy was executed as planned. A total of 358 patients were included, resulting in 45,113 monitored hours during 6142 nurse shifts. In total, 10.3% (37/358) of the sensors were replaced prematurely because of technical failure. Mean intervention fidelity was 70.7% (SD 20.4%) and higher in the surgical ward (73.6%, SD 18.1% vs 64.1%, SD 23.7%; P<.001). Fidelity decreased over the implementation period in the internal medicine ward (76%, 57%, and 48% at early, mid-, and late implementation, respectively; P<.001) but not significantly in the surgical ward (76% at early implementation vs 74% at midimplementation [P=.56] vs 70.7% at late implementation [P=.07]). No nursing activities were needed based on vital sign trends for 68.7% (246/358) of the patients. In 174 reports of 31.3% (112/358) of the patients, observed deviating trends led to 101 additional bedside assessments of patients and 73 consultations by physicians. The main themes that emerged during interviews (n=21) included the relative priority of CMVS in nurse work, the importance of nursing assessment, the relatively limited perceived benefits for patient care, and experienced mediocre usability of the technology.ConclusionsWe successfully implemented a system for CMVS at scale in 2 hospital wards, but our results show that intervention fidelity decreased over time, more in the internal medicine ward than in the surgical ward. This decrease appeared to depend on multiple ward-specific factors. Nurses' perceptions regarding the value and benefits of the intervention varied. Implications for optimal implementation of CMVS include engaging nurses early, seamless integration into electronic health records, and sophisticated decision support tools for vital sign trend interpretation.

Project description:BackgroundTechnological advances have enabled continuous monitoring of vital signs (CMVS) by wearable, wireless devices on general hospital wards to facilitate early detection of clinical deterioration, which could potentially improve clinical outcomes. However, evidence on the impact of these CMVS systems on patient outcomes is limited. This research aimed to explore the effect of CMVS on the clinical outcomes in major abdominal surgery patients in a general surgery ward.MethodsA single-centre before-after study was conducted from October 2019 to June 2022. Patients in the intervention group received CMVS in addition to conventional intermittent vital sign monitoring (standard care for control group). With CMVS, heart rate and respiratory rate were measured every 5 min by a patch sensor. Proactive vital signs trends assessments and, when necessary, subsequent nursing activities were performed every nursing shift. The primary outcome of interest was the length of hospital stay (LOS); also, 12 patient-related outcomes were analysed. In the CMVS group, follow-up nursing activities of deviating vital signs trends were described and patient acceptability was measured. Post-hoc subgroup analysis was performed for colorectal and hepatopancreatobiliary surgery.ResultsA total of 908 patients were included (colorectal: n = 650; hepatopancreatobiliary: n = 257). Overall, median LOS was lower in the CMVS group (5.0 versus 5.5 days; P = 0.012), respectively. Post-hoc subgroup analysis showed this reduction in LOS was mostly observed in the colorectal group and not in the hepatopancreatobiliary group. Apart from a decrease in nurse-to-house-officer calls (from 15.3% to 7.7%; P = 0.007), all secondary clinical outcomes were similar in CMVS and control groups. However, a non-significant trend towards less-severe complications and reduced ICU LOS was observed in the CMVS group. In CMVS patients, 109 additional nursing activities were performed and 83% of patients indicated CMVS was acceptable.ConclusionCMVS was associated with a significant reduction in LOS, while other clinical outcomes were unchanged. CMVS triggered additional nursing activities such as extra patient assessments and therapeutic interventions.

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:BackgroundContinuous monitoring using wireless wearable sensors is a promising solution for use in clinical practice and in the home setting. It is important to involve nurses to ensure successful implementation. This paper aims to provide an overview of 1) factors affecting implementation of continuous monitoring using wireless wearable sensors by evaluating nurses' experiences with its use on the nursing ward, and 2) nurses' expectations for use in the home setting.MethodsSemi-structured interviews were conducted with 16 nurses from three teaching hospitals in the Netherlands, covering constructs from the Consolidated Framework for Implementation Research (CFIR). A deductive approach of directed content analysis was applied. One additional factor was added using the Unified Theory for Acceptance of Technology (UTAUT). The quotes and domains were rated on valence (positive, neutral, negative) and strength (strong: - 2, + 2, neutral 0, and weak: - 1, + 1).ResultsData was collected on 27 CFIR constructs and 1 UTAUT construct. In the experience of at least 8 nurses, five constructs had a strong positive influence on implementation on the nursing ward, including relative advantage (e.g., early detection of deterioration), patient needs and resources (e.g. feeling safe), networks and communications (e.g. execute tasks together), personal attributes (e.g. experience with intervention), and implementation leaders (e.g., project leader). Five constructs had a strong negative influence: evidence strength and quality (e.g. lack of evidence from practical experience), complexity (e.g. number of process steps), design quality and packaging (e.g., bad sensor quality), compatibility (e.g, change in work) and facilitating conditions (e.g, Wi-Fi connection). Nurses expected continuous monitoring in the home setting to be hindered by compatibility with work processes and to be facilitated by staff's access to information. Technical facilitating conditions (e.g. interoperability) were suggested to be beneficial for further development.ConclusionsThis paper provides an overview, of factors influencing implementation of continuous monitoring including relative importance, based on nurses' experiences with use on nursing wards, and their perspectives for use in the home setting. Implementation of continuous monitoring is affected by a wide range of factors. This overview may be used as a guideline for future implementations.

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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