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Continuous Versus Intermittent Vital Signs Monitoring Using a Wearable, Wireless Patch in Patients Admitted to Surgical Wards: Pilot Cluster Randomized Controlled Trial.

ABSTRACT: 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).

SUBMITTER: Downey C

PROVIDER: S-EPMC6305881 | biostudies-other | 2018 Dec

REPOSITORIES: biostudies-other

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Continuous Versus Intermittent Vital Signs Monitoring Using a Wearable, Wireless Patch in Patients Admitted to Surgical Wards: Pilot Cluster Randomized Controlled Trial.

Downey Candice C Randell Rebecca R Brown Julia J Jayne David G DG

Journal of medical Internet research 20181211 12

<h4>Background</h4>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.<h4>Objective</h4>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 optim ...[more]

PMID: 30538086

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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: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.

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:Background:Respiratory depression is a serious perioperative complication associated with morbidity and mortality. Recently, technology has become available to wirelessly monitor patients on regular surgical wards with continuous pulse oximetry and wireless clinician notification with alarms. When a patient's SpO2 falls below a set threshold, the clinician is notified via a pager and may intervene earlier to prevent further clinical deterioration. To date, the technology has not been evaluated with a randomized controlled trial (RCT). Methods:We designed a parallel-group unblinded pilot RCT of a wireless monitoring system on two surgical wards in an academic teaching hospital. Postsurgical patients with an anticipated length of stay of at least 1?day were included and randomized to standard care or standard care plus wireless respiratory monitoring for up to a 72-h period. The primary outcomes were feasibility outcomes: average patients recruited per week and tolerability of the system by patients. Secondary outcomes included (1) respiratory events (naloxone administration for respiratory depression, ICU transfers, and cardiac arrest team activation) and (2) system alarm types and details. The analysis of the outcomes was based on descriptive statistics and estimates reported using point (95% confidence intervals). Criteria for success of feasibility were recruitment of an average of 15 patients/week and 90% of the patients tolerating the system. Results:The pilot trial enrolled 250 of the 335 patients screened for eligibility, with 126 and 124 patients entering the standard monitoring and wireless groups, respectively. Baseline demographics were similar between groups, except for slightly more women in the wireless group. Average patient recruitment per week was 14 95% CI [12, 16] patients. The wireless monitoring was quite tolerable with 86.6% (95% CI 78.2-92.7%) of patients completing the full course, and there were no other adverse events directly attributable to the monitoring. With regard to secondary outcomes, the respiratory event rate was low with only 1 event in the wireless group and none in the control group. The average number of alarms per week was 4.0 (95% CI, 1.6-6.4). Conclusions:This pilot study demonstrated adequate patient recruitment and high tolerability of the wireless monitoring system. A full RCT that is powered to detect patient important outcomes such as respiratory depression is now underway. Trial registration:ClinicalTrials.gov, Registration number NCT02907255, registered 7 September 2016-retrospectively registered.

Project description:ObjectivesTo evaluate a new-generation, non-invasive, wireless axillary thermometer with artificial intelligence, iThermonitor (WT705, Raiing Medical, Beijing, China), and to ascertain its feasibility for perioperative continuous body temperature monitoring in surgical patients.SettingDepartments of Biliary Surgery and Operating Room and the post-anaesthesia care unit of a university teaching hospital in Chengdu, China.ParticipantsA total of 526 adult surgical patients were consecutively enrolled.DesignThis was a prospective observational study. Axillary temperatures were continuously recorded with iThermonitor throughout the whole perioperative period. The temperatures of the contralateral armpit were measured with mercury thermometers at 8:00, 12:00, 16:00 and 20:00 every day and were used as references.Outcome measuresThe outcomes were the accuracy and precision of the temperatures measured with iThermonitor, the validity to detect fever and the feasibility of continuous wear. Pairs of temperatures were evaluated with Student's t-test, Pearson's correlation and repeated-measures Bland-Altman plot.ResultsA total of 3621 pairs of body temperatures were obtained. The temperatures measured with iThermonitor agreed with those measured with the mercury thermometers overall, with a mean difference of 0.03°C±0.35°C and a moderate correlation (r=0.755, p<0.001). The 95% limits of agreement (LoA) ranged from -0.63°C to 0.73°C, with 5.11% of the differences outside the 95% LoA. The intraclass correlation coefficient was 0.753. Continuous temperature monitoring captured more fevers than intermittent observation (117/526 vs 91/526, p<0.001), detected fever up to 4.35 hours earlier, and captured a higher peak temperature (0.29°C±0.27°C, 95% CI: 0.26-0.31). All subjects felt that wearing iThermonitor was more or less comfortable and did not affect their daily activities.ConclusionsiThermonitor is promising for continuous remote temperature monitoring in surgical patients. However, further developments are still needed to improve the precision of this device, especially for temperature detection in underweight patients and those with lower body temperature.Trial registration numberChiCTR1900024549; Results (registered on 5 July 2019).

Dataset Information

Continuous Versus Intermittent Vital Signs Monitoring Using a Wearable, Wireless Patch in Patients Admitted to Surgical Wards: Pilot Cluster Randomized Controlled Trial.

Publications

Continuous Versus Intermittent Vital Signs Monitoring Using a Wearable, Wireless Patch in Patients Admitted to Surgical Wards: Pilot Cluster Randomized Controlled Trial.

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