Screening for postoperative vital signs abnormalities, and particularly hemodynamic ones, by continuous monitoring: protocol for the Biobeat-Postop cohort study [version 2; peer review: 2 approved]
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SUBMITTER: Paternot A
PROVIDER: S-EPMC8546735 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundPatients undergoing major surgery are at risk of complications, so-called serious adverse events (SAE). Continuous monitoring may detect deteriorating patients by recording abnormal vital signs. We aimed to assess the association between abnormal vital signs inspired by Early Warning Score thresholds and subsequent SAEs in patients undergoing major abdominal surgery.MethodsProspective observational cohort study continuously monitoring heart rate, respiratory rate, peripheral oxygen saturation, and blood pressure for up to 96 h in 500 postoperative patients admitted to the general ward. Exposure variables were vital sign abnormalities, primary outcome was any serious adverse event occurring within 30 postoperative days. The primary analysis investigated the association between exposure variables per 24 h and subsequent serious adverse events.ResultsSerious adverse events occurred in 37% of patients, with 38% occurring during monitoring. Among patients with SAE during monitoring, the median duration of vital sign abnormalities was 272 min (IQR 110-447), compared to 259 min (IQR 153-394) in patients with SAE after monitoring and 261 min (IQR 132-468) in the patients without any SAE (p = .62 for all three group comparisons). Episodes of heart rate ≥110 bpm occurred in 16%, 7.1%, and 3.9% of patients in the time before SAE during monitoring, after monitoring, and without SAE, respectively (p < .002). Patients with SAE after monitoring experienced more episodes of hypotension ≤90 mm Hg/24 h (p = .001).ConclusionOverall duration of vital sign abnormalities at current thresholds were not significantly associated with subsequent serious adverse events, but more patients with tachycardia and hypotension had subsequent serious adverse events.Trial registrationClinicaltrials.gov, identifier NCT03491137.
| S-EPMC9310747 | biostudies-literature
Project description:In recent years, noncontact measurements of vital signs using cameras received a great amount of interest. However, some questions are unanswered: (i) Which vital sign is monitored using what type of camera? (ii) What is the performance and which factors affect it? (iii) Which health issues are addressed by camera-based techniques? Following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement, we conduct a systematic review of continuous camera-based vital sign monitoring using Scopus, PubMed, and the Association for Computing Machinery (ACM) databases. We consider articles that were published between January 2018 and April 2021 in the English language. We include five vital signs: heart rate (HR), respiratory rate (RR), blood pressure (BP), body skin temperature (BST), and oxygen saturation (SpO2). In total, we retrieve 905 articles and screened them regarding title, abstract, and full text. One hundred and four articles remained: 60, 20, 6, 2, and 1 of the articles focus on HR, RR, BP, BST, and SpO2, respectively, and 15 on multiple vital signs. HR and RR can be measured using red, green, and blue (RGB) and near-infrared (NIR) as well as far-infrared (FIR) cameras. So far, BP and SpO2 are monitored with RGB cameras only, whereas BST is derived from FIR cameras only. Under ideal conditions, the root mean squared error is around 2.60 bpm, 2.22 cpm, 6.91 mm Hg, 4.88 mm Hg, and 0.86 °C for HR, RR, systolic BP, diastolic BP, and BST, respectively. The estimated error for SpO2 is less than 1%, but it increases with movements of the subject and the camera-subject distance. Camera-based remote monitoring mainly explores intensive care, post-anaesthesia care, and sleep monitoring, but also explores special diseases such as heart failure. The monitored targets are newborn and pediatric patients, geriatric patients, athletes (e.g., exercising, cycling), and vehicle drivers. Camera-based techniques monitor HR, RR, and BST in static conditions within acceptable ranges for certain applications. The research gaps are large and heterogeneous populations, real-time scenarios, moving subjects, and accuracy of BP and SpO2 monitoring.
| S-EPMC9185528 | biostudies-literature
Project description:Continuous vital signs monitoring in post-surgical ward patients may support early detection of clinical deterioration, but novel alarm approaches are required to ensure timely notification of abnormalities and prevent alarm-fatigue. The current study explored the performance of classical and various adaptive threshold-based alarm strategies to warn for vital sign abnormalities observed during development of an adverse event. A classical threshold-based alarm strategy used for continuous vital signs monitoring in surgical ward patients was evaluated retrospectively. Next, (combinations of) six methods to adapt alarm thresholds to personal or situational factors were simulated in the same dataset. Alarm performance was assessed using the overall alarm rate and sensitivity to detect adverse events. Using a wireless patch-based monitoring system, 3999 h of vital signs data was obtained in 39 patients. The clinically used classical alarm system produced 0.49 alarms/patient/day, and alarms were generated for 11 out of 18 observed adverse events. Each of the tested adaptive strategies either increased sensitivity to detect adverse events or reduced overall alarm rate. Combining specific strategies improved overall performance most and resulted in earlier presentation of alarms in case of adverse events. Strategies that adapt vital sign alarm thresholds to personal or situational factors may improve early detection of adverse events or reduce alarm rates as compared to classical alarm strategies. Accordingly, further investigation of the potential of adaptive alarms for continuous vital signs monitoring in ward patients is warranted.
| S-EPMC9123069 | biostudies-literature
Project description:Wireless vital signs sensors are increasingly used for remote patient monitoring, but data analysis is often challenged by missing data periods. This study explored the performance of various imputation techniques for continuous vital signs measurements. Wireless vital signs measurements (heart rate, respiratory rate, blood oxygen saturation, axillary temperature) from surgical ward patients were used for repeated random simulation of missing data periods (gaps) of 5-60 min in two-hour windows. Gaps were imputed using linear interpolation, spline interpolation, last observation- and mean carried forwards technique, and cluster-based prognosis. Imputation performance was evaluated using the mean absolute error (MAE) between original and imputed gap samples. Besides, effects on signal features (window's slope, mean) and early warning scores (EWS) were explored. Gaps were simulated in 1743 data windows, obtained from 52 patients. Although MAE ranges overlapped, median MAE was structurally lowest for linear interpolation (heart rate: 0.9-2.6 beats/min, respiratory rate: 0.8-1.8 breaths/min, temperature: 0.04-0.17 °C, oxygen saturation: 0.3-0.7% for 5-60 min gaps) but up to twice as high for other techniques. Three techniques resulted in larger ranges of signal feature bias compared to no imputation. Imputation led to EWS misclassification in 1-8% of all simulations. Imputation error ranges vary between imputation techniques and increase with gap length. Imputation may result in larger signal feature bias compared to performing no imputation, and can affect patient risk assessment as illustrated by the EWS. Accordingly, careful implementation and selection of imputation techniques is warranted.
| S-EPMC9893204 | biostudies-literature
Project description:BackgroundMeasurement of vital signs in hospitalized patients is necessary to assess the clinical situation of the patient. Early warning scores (EWS), such as the modified early warning score (MEWS), are generally calculated 3 times a day, but these may not capture early deterioration. A delay in diagnosing deterioration is associated with increased mortality. Continuous monitoring with wearable devices might detect clinical deterioration at an earlier stage, which allows clinicians to take corrective actions.ObjectiveIn this pilot study, the feasibility of continuous monitoring using the ViSi Mobile (VM; Sotera Wireless) and HealthPatch (HP; Vital Connect) was tested, and the experiences of patients and nurses were collected.MethodsIn this feasibility study, 20 patients at the internal medicine and surgical ward were monitored with VM and HP simultaneously for 2 to 3 days. Technical problems were analyzed. Vital sign measurements by nurses were taken as reference and compared with vital signs measured by both devices. Patient and nurse experiences were obtained by semistructured interviews.ResultsIn total, 86 out of 120 MEWS measurements were used for the analysis. Vital sign measurements by VM and HP were generally consistent with nurse measurements. In 15% (N=13) and 27% (N=23) of the VM and HP cases respectively, clinically relevant differences in MEWS were found based on inconsistent respiratory rate registrations. Connection failure was recognized as a predominant VM artifact (70%). Over 50% of all HP artifacts had an unknown cause, were self-limiting, and never took longer than 1 hour. The majority of patients, relatives, and nurses were positive about VM and HP.ConclusionsBoth VM and HP are promising for continuously monitoring vital signs in hospitalized patients, if the frequency and duration of artifacts are reduced. The devices were well received and comfortable for most patients.
| S-EPMC5517820 | biostudies-literature
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.
| S-EPMC7315364 | biostudies-literature
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.
| S-EPMC7351263 | biostudies-literature
Project description:BackgroundPatients undergoing esophagectomy are at serious risk of developing postoperative complications. To support early recognition of clinical deterioration, wireless sensor technologies that enable continuous vital signs monitoring in a ward setting are emerging.ObjectiveThis study explored nurses' and surgeons' expectations of the potential effectiveness and impact of continuous wireless vital signs monitoring in patients admitted to the ward after esophagectomy.MethodsSemistructured interviews were conducted at 3 esophageal cancer centers in the Netherlands. In each center, 2 nurses and 2 surgeons were interviewed regarding their expectations of continuous vital signs monitoring for early recognition of complications after esophagectomy. Historical data of patient characteristics and clinical outcomes were collected in each center and presented to the local participants to support estimations on clinical outcome.ResultsThe majority of nurses and surgeons expected that continuous vital signs monitoring could contribute to the earlier recognition of deterioration and result in earlier treatment for postoperative complications, although the effective time gain would depend on patient and situational factors. Their expectations regarding the impact of potential earlier diagnosis on clinical outcomes varied. Nevertheless, most caregivers would consider implementing continuous monitoring in the surgical ward to support patient monitoring after esophagectomy.ConclusionsCaregivers expected that wireless vital signs monitoring would provide opportunities for early detection of postoperative complications in patients undergoing esophagectomy admitted to the ward and prevent sequelae under certain circumstances. As the technology matures, clinical outcome studies will be necessary to objectify these expectations and further investigate overall effects on patient outcome.
| S-EPMC7910120 | biostudies-literature
Project description:Technological advances seen in recent years have introduced the possibility of changing the way hospitalized patients are monitored by abolishing the traditional track-and-trigger systems and implementing continuous monitoring using wearable biosensors. However, this new monitoring paradigm raise demand for novel ways of analyzing the data streams in real time. The aim of this study was to design a stability index using kernel density estimation (KDE) fitted to observations of physiological stability incorporating the patients' circadian rhythm. Continuous vital sign data was obtained from two observational studies with 491 postoperative patients and 200 patients with acute exacerbation of chronic obstructive pulmonary disease. We defined physiological stability as the last 24 h prior to discharge. We evaluated the model against periods of eight hours prior to events defined either as severe adverse events (SAE) or as a total score in the early warning score (EWS) protocol of ≥ 6, ≥ 8, or ≥ 10. The results found good discriminative properties between stable physiology and EWS-events (area under the receiver operating characteristics curve (AUROC): 0.772-0.993), but lower for the SAEs (AUROC: 0.594-0.611). The time of early warning for the EWS events were 2.8-5.5 h and 2.5 h for the SAEs. The results showed that for severe deviations in the vital signs, the circadian KDE model can alert multiple hours prior to deviations being noticed by the staff. Furthermore, the model shows good generalizability to another cohort and could be a simple way of continuously assessing patient deterioration in the general ward.
| S-EPMC10651555 | biostudies-literature
Project description:ObjectivesPostoperative deviating physiologic values (vital signs) may represent postoperative stress or emerging complications. But they can also reflect chronic preoperative values. Distinguishing between the two circumstances may influence the utility of using vital signs in patient monitoring. Thus, we aimed to describe the occurrence of vital sign deviations before and after major vascular surgery, hypothesising that preoperative vital sign deviations were longer in duration postoperatively.MethodsIn this prospective observational study, arterial vascular patients were continuously monitored wirelessly - from the day before until 5 days after surgery. Recorded values were: heart rate, respiration rate, peripheral arterial oxygen saturation (SpO2 ) and blood pressure. The outcomes were 1. cumulative duration of SpO2 < 85% / 24 h, and 2. cumulative duration per 24 h of vital sign deviations.ResultsForty patients were included with a median monitoring time of 21 h preoperatively and 42 h postoperatively. The median duration of SpO2 < 85% preoperatively was 14.4 min/24 h whereas it was 28.0 min/24 h during day 0 in the ward (p = .09), and 16.8 min/24 h on day 1 in the ward (p = 0.61). Cumulative duration of SpO2 < 80% was significantly longer on day 0 in the ward 2.4 min/24 h (IQR 0.0-4.6) versus 6.7 min/24 h (IQR 1.8-16.2) p = 0.01.ConclusionDeviating physiology is common in patients before and after vascular surgery. A longer duration of severe desaturation was found on the first postoperative day in the ward compared to preoperatively, whereas moderate desaturations were reflected in postoperative desaturations. Cumulative duration outside thresholds is, in some cases, exacerbated after surgery.
| S-EPMC10092470 | biostudies-literature