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: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:ObjectiveTo determine feasibility, in terms of acceptability and system fidelity, of continuous vital signs monitoring in abdominal surgery patients on a general ward.DesignObservational cohort study.SettingTertiary teaching hospital.ParticipantsPostoperative abdominal surgical patients (n=30) and nurses (n=23).InterventionsPatients were continuously monitored with the SensiumVitals wearable device until discharge in addition to usual care, which is intermittent Modified Early Warning Score measurements. Heart rate, respiratory rate and axillary temperature were monitored every 2?min. Values and trends were visualised and alerts sent to the nurses.OutcomesSystem fidelity was measured by analysis of the monitoring data. Acceptability by patients and nurses was assessed using questionnaires.ResultsThirty patients were monitored for a median duration of 81?hours (IQR 47-143) per patient, resulting in 115?217 measurements per parameter. In total, 19% (n=21?311) of heart rate, 51% (n=59?184) of respiratory rate and 9% of temperature measurements showed artefacts (n=10?269). The system algorithm sent 972 alerts (median alert rate of 4.5 per patient per day), of which 90.3% (n=878) were system alerts and 9.7% (n=94) were vital sign alerts. 35% (n=33) of vital sign alerts were true positives. 93% (n=25) of patients rated the patch as comfortable, 67% (n=18) felt safer and 89% (n=24) would like to wear it next time in the hospital. Nurses were neutral about usefulness, with a median score of 3.5 (IQR 3.1-4) on a 7-point Likert scale, ease of use 3.7 (IQR 3.2-4.8) and satisfaction 3.7 (IQR 3.2-4.8), but agreed on ease of learning at 5.0 (IQR 4.0-5.8). Neutral scores were mostly related to the perceived limited fidelity of the system.ConclusionsContinuous monitoring of vital signs with a wearable device was well accepted by patients. Nurses' ratings were highly variable, resulting in on average neutral attitude towards remote monitoring. Our results suggest it is feasible to monitor vital signs continuously on general wards, although acceptability of the device among nurses needs further improvement.
| S-EPMC7893648 | biostudies-literature
Project description:It has been the dream of many scientists and engineers to realize a non-contact remote sensing system that can perform continuous, accurate and long-term monitoring of human vital signs as we have seen in many Sci-Fi movies. Having an intelligible sensor system that can measure and record key vital signs (such as heart rates and respiration rates) remotely and continuously without touching the patients, for example, can be an invaluable tool for physicians who need to make rapid life-and-death decisions. Such a sensor system can also effectively help physicians and patients making better informed decisions when patients' long-term vital signs data is available. Therefore, there has been a lot of research activities on developing a non-contact sensor system that can monitor a patient's vital signs and quickly transmit the information to healthcare professionals. Doppler-based radio-frequency (RF) non-contact vital signs (NCVS) monitoring system are particularly attractive for long term vital signs monitoring because there are no wires, electrodes, wearable devices, nor any contact-based sensors involved so the subjects may not be even aware of the ubiquitous monitoring. In this paper, we will provide a brief review on some latest development on NCVS sensors and compare them against a few novel and intelligent phased-array Doppler-based RF NCVS biosensors we have built in our labs. Some of our NCVS sensor tests were performed within a clutter-free anechoic chamber to mitigate the environmental clutters, while most tests were conducted within the typical Herman-Miller type office cubicle setting to mimic a more practical monitoring environment. Additionally, we will show the measurement data to demonstrate the feasibility of long-term NCVS monitoring. The measured data strongly suggests that our latest phased array NCVS system should be able to perform long-term vital signs monitoring intelligently and robustly, especially for situations where the subject is sleeping without hectic movements nearby.
| S-EPMC5713025 | biostudies-other
Project description:A highly flexible, stretchable, and mechanically robust low-cost soft composite consisting of silicone polymers and water (or hydrogels) is reported. When combined with conventional acoustic transducers, the materials reported enable high performance real-time monitoring of heart and respiratory patterns over layers of clothing (or furry skin of animals) without the need for direct contact with the skin. The approach enables an entirely new method of fabrication that involves encapsulation of water and hydrogels with silicones and exploits the ability of sound waves to travel through the body. The system proposed outperforms commercial, metal-based stethoscopes for the auscultation of the heart when worn over clothing and is less susceptible to motion artefacts. The system both with human and furry animal subjects (i.e., dogs), primarily focusing on monitoring the heart, is tested; however, initial results on monitoring breathing are also presented. This work is especially important because it is the first demonstration of a stretchable sensor that is suitable for use with furry animals and does not require shaving of the animal for data acquisition.
| S-EPMC7116191 | biostudies-literature
Project description:Major surgeries can result in high rates of adverse postoperative events. Reliable prediction of which patient might be at risk for such events may help guide peri- and postoperative care. We show how archiving and mining of intraoperative hemodynamic data in orthotopic liver transplantation (OLT) can aid in the prediction of postoperative 180-day mortality and acute renal failure (ARF), improving upon predictions that rely on preoperative information only. From 101 patient records, we extracted 15 preoperative features from clinical records and 41 features from intraoperative hemodynamic signals. We used logistic regression with leave-one-out cross-validation to predict outcomes, and incorporated methods to limit potential model instabilities from feature multicollinearity. Using only preoperative features, mortality prediction achieved an area under the receiver operating characteristic curve (AUC) of 0.53 (95% CI: 0.44-0.78). By using intraoperative features, performance improved significantly to 0.82 (95% CI: 0.56-0.91, P?=?0.001). Similarly, including intraoperative features (AUC?=?0.82; 95% CI: 0.66-0.94) in ARF prediction improved performance over preoperative features (AUC?=?0.72; 95% CI: 0.50-0.85), though not significantly (P?=?0.32). We conclude that inclusion of intraoperative hemodynamic features significantly improves prediction of postoperative events in OLT. Features strongly associated with occurrence of both outcomes included greater intraoperative central venous pressure and greater transfusion volumes.
| S-EPMC5703992 | biostudies-literature
Project description:BACKGROUND: In Japan, the circumstances in which pharmacists work are changing. Pharmacists are expected to assess conditions of patients subject to medication to ensure proper use of pharmaceutical products. To ensure fulfilment of these roles, there have already been pharmacists' efforts in performing vital signs monitoring. OBJECTIVE: To clarify the necessity and related issues, by investigating the state of vital sign monitoring in clinical field by pharmacists who have been trained in vital sign monitoring. METHOD: A web survey was conducted from 4th October to 3rd December 2012, subjecting 1,026 pharmacists who completed the vital signs training hosted by The Japanese Association of Home Care Pharmacies (JAHCP). Survey items were 1) basic information of a respondent, 2) situation of homecare conducted by pharmacists, 3) seminar attendance status, and 4) vital signs monitoring status after the seminar. RESULTS: The number of valid respondents was 430 and the response rate was 41.9%. As a result of the present research, it was revealed that 168 pharmacists (41.4%), had the opportunity to perform vital signs monitoring. By conducting vital sign monitoring, effects such as 1) improved motivation of pharmacists and better communication with patients, 2) proper use of medication, and 3) cost reduction were confirmed. CONCLUSION: Judging from the results of the survey, pharmacists can improve medication therapy for patients by attaining vital sign skills and conduct vital sign monitoring. Pharmacists who perform vital sign monitoring should share cases where they experienced positive patient outcomes.
| S-EPMC4161410 | biostudies-other