Continuous monitoring of vital sign abnormalities; association to clinical complications in 500 postoperative patients.
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ABSTRACT: Background
Patients 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.Methods
Prospective 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.Results
Serious 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).Conclusion
Overall 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 registration
Clinicaltrials.gov, identifier NCT03491137.
SUBMITTER: Haahr-Raunkjaer C
PROVIDER: S-EPMC9310747 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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
Project description:BackgroundThe standard of care in general wards includes periodic manual measurements, with the data entered into track-and-trigger charts, either on paper or electronically. Wearable devices may support health care staff, improve patient safety, and promote early deterioration detection in the interval between periodic measurements. However, regulatory standards for ambulatory cardiac monitors estimating heart rate (HR) and respiratory rate (RR) do not specify performance criteria during patient movement or clinical conditions in which the patient's oxygen saturation varies. Therefore, further validation is required before clinical implementation and deployment of any wearable system that provides continuous vital sign measurements.ObjectiveThe objective of this study is to determine the agreement between a chest-worn patch (VitalPatch) and a gold standard reference device for HR and RR measurements during movement and gradual desaturation (modeling a hypoxic episode) in a controlled environment.MethodsAfter the VitalPatch and gold standard devices (Philips MX450) were applied, participants performed different movements in seven consecutive stages: at rest, sit-to-stand, tapping, rubbing, drinking, turning pages, and using a tablet. Hypoxia was then induced, and the participants' oxygen saturation gradually reduced to 80% in a controlled environment. The primary outcome measure was accuracy, defined as the mean absolute error (MAE) of the VitalPatch estimates when compared with HR and RR gold standards (3-lead electrocardiography and capnography, respectively). We defined these as clinically acceptable if the rates were within 5 beats per minute for HR and 3 respirations per minute (rpm) for RR.ResultsComplete data sets were acquired for 29 participants. In the movement phase, the HR estimates were within prespecified limits for all movements. For RR, estimates were also within the acceptable range, with the exception of the sit-to-stand and turning page movements, showing an MAE of 3.05 (95% CI 2.48-3.58) rpm and 3.45 (95% CI 2.71-4.11) rpm, respectively. For the hypoxia phase, both HR and RR estimates were within limits, with an overall MAE of 0.72 (95% CI 0.66-0.78) beats per minute and 1.89 (95% CI 1.75-2.03) rpm, respectively. There were no significant differences in the accuracy of HR and RR estimations between normoxia (≥90%), mild (89.9%-85%), and severe hypoxia (<85%).ConclusionsThe VitalPatch was highly accurate throughout both the movement and hypoxia phases of the study, except for RR estimation during the two types of movements. This study demonstrated that VitalPatch can be safely tested in clinical environments to support earlier detection of cardiorespiratory deterioration.Trial registrationISRCTN Registry ISRCTN61535692; https://www.isrctn.com/ISRCTN61535692.
| S-EPMC8482195 | biostudies-literature
Project description:Background: Postoperative hypotension associated with postoperative morbidity and early mortality has been studied previously. Hypertension and other hemodynamic, respiratory, and temperature abnormalities have comparatively understudied during the first postoperative days. Methods: This bi-centre observational cohort study will include 114 adult patients undergoing non-cardiac surgery hospitalized on an unmonitored general care floor and wearing a multi-signal wearable sensor, allowing remote monitoring ( Biobeat Technologies Ltd, Petah Tikva, Israel). The study will cover the first 72 hours after discharge of the patient from the post-anaesthesia care unit. Several thresholds will be used for each variable (arterial pressure, heart rate, respiratory rate, oxygen saturation, and skin temperature). Data obtained using the sensor will be compared to data obtained during the routine nurse follow-up. The primary outcome is hemodynamic abnormality. The secondary outcomes are postoperative respiratory and temperature abnormalities, artefacts and blank/null outputs from the wearable device, postoperative complications, and finally, the ease of use of the device. We hypothesize that remote monitoring will detect abnormalities in vital signs more often or more quickly than the detection by nurses' routine surveillance. Discussion: A demonstration of the ability of wireless sensors to outperform standard monitoring techniques paves the way for the creation of a loop which includes this monitoring mode, the automated creation of alerts, and the sending of these alerts to caregivers. Trial registration: ClinicalTrials.gov, NCT04585178. Registered on October 14, 2020.
| S-EPMC8546735 | biostudies-literature
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.
| S-EPMC10794900 | biostudies-literature
Project description:The COVID-19 pandemic has accelerated methods to facilitate contactless evaluation of patients in hospital settings. By minimizing in-person contact with individuals who may have COVID-19, healthcare workers can prevent disease transmission and conserve personal protective equipment. Obtaining vital signs is a ubiquitous task that is commonly done in person by healthcare workers. To eliminate the need for in-person contact for vital sign measurement in the hospital setting, we developed Dr. Spot, a mobile quadruped robotic system. The system includes IR and RGB cameras for vital sign monitoring and a tablet computer for face-to-face medical interviewing. Dr. Spot is teleoperated by trained clinical staff to simultaneously measure the skin temperature, respiratory rate, and heart rate while maintaining social distancing from patients and without removing their mask. To enable accurate, contactless measurements on a mobile system without a static black body as reference, we propose novel methods for skin temperature compensation and respiratory rate measurement at various distances between the subject and the cameras, up to 5 m. Without compensation, the skin temperature MAE is 1.3°C. Using the proposed compensation method, the skin temperature MAE is reduced to 0.3°C. The respiratory rate method can provide continuous monitoring with a MAE of 1.6 BPM in 30 s or rapid screening with a MAE of 2.1 BPM in 10 s. For the heart rate estimation, our system is able to achieve a MAE less than 8 BPM in 10 s measured in arbitrary indoor light conditions at any distance below 2 m.
| S-EPMC9096356 | biostudies-literature
Project description:BackgroundRespiratory 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).MethodsWe 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.ResultsThe 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).ConclusionsThis 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 registrationClinicalTrials.gov, Registration number NCT02907255, registered 7 September 2016-retrospectively registered.
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Project description:BackgroundTimely recognition of the deteriorating inpatient remains challenging. Wearable monitoring systems (WMS) may augment current monitoring practices. However, there are many barriers to implementation in the hospital environment, and evidence describing the clinical impact of WMS on deterioration detection and patient outcome remains unclear.ObjectiveTo assess the impact of vital-sign monitoring on detection of deterioration and related clinical outcomes in hospitalised patients using WMS, in comparison with standard care.MethodsA systematic search was conducted in August 2020 using MEDLINE, Embase, CINAHL, Cochrane Database of Systematic Reviews, CENTRAL, Health Technology Assessment databases and grey literature. Studies comparing the use of WMS against standard care for deterioration detection and related clinical outcomes in hospitalised patients were included. Deterioration related outcomes (primary) included unplanned intensive care admissions, rapid response team or cardiac arrest activation, total and major complications rate. Other clinical outcomes (secondary) included in-hospital mortality and hospital length of stay. Exploratory outcomes included alerting system parameters and clinical trial registry information.ResultsOf 8706 citations, 10 studies with different designs met the inclusion criteria, of which 7 were included in the meta-analyses. Overall study quality was moderate. The meta-analysis indicated that the WMS, when compared with standard care, was not associated with significant reductions in intensive care transfers (risk ratio, RR 0.87; 95% confidence interval, CI 0.66-1.15), rapid response or cardiac arrest team activation (RR 0.84; 95% CI 0.69-1.01), total (RR 0.77; 95% CI 0.44-1.32) and major (RR 0.55; 95% CI 0.24-1.30) complications prevalence. There was also no statistically significant association with reduced mortality (RR 0.48; 95% CI 0.18-1.29) and hospital length of stay (mean difference, MD - 0.09; 95% CI - 0.43 to 0.44).ConclusionThis systematic review indicates that there is no current evidence that implementation of WMS impacts early deterioration detection and associated clinical outcomes, as differing design/quality of available studies and diversity of outcome measures make it difficult to reach a definite conclusion. Our narrative findings suggested that alarms should be adjusted to minimise false alarms and promote rapid clinical action in response to deterioration. PROSPERO Registration number: CRD42020188633 .
| S-EPMC8477465 | biostudies-literature
Project description:BackgroundVital signs, i.e. respiratory rate, oxygen saturation, pulse, blood pressure and temperature, are regarded as an essential part of monitoring hospitalized patients. Changes in vital signs prior to clinical deterioration are well documented and early detection of preventable outcomes is key to timely intervention. Despite their role in clinical practice, how to best monitor and interpret them is still unclear.ObjectiveTo evaluate the ability of vital sign trends to predict clinical deterioration in patients hospitalized with acute illness.Data sourcesPubMed, Embase, Cochrane Library and CINAHL were searched in December 2017.Study selectionStudies examining intermittently monitored vital sign trends in acutely ill adult patients on hospital wards and in emergency departments. Outcomes representing clinical deterioration were of interest.Data extractionPerformed separately by two authors using a preformed extraction sheet.ResultsOf 7,366 references screened, only two were eligible for inclusion. Both were retrospective cohort studies without controls. One examined the accuracy of different vital sign trend models using discrete-time survival analysis in 269,999 admissions. One included 44,531 medical admissions examining trend in Vitalpac Early Warning Score weighted vital signs. They stated that vital sign trends increased detection of clinical deterioration. Critical appraisal was performed using evaluation tools. The studies had moderate risk of bias, and a low certainty of evidence. Additionally, four studies examining trends in early warning scores, otherwise eligible for inclusion, were evaluated.ConclusionsThis review illustrates a lack of research in intermittently monitored vital sign trends. The included studies, although heterogeneous and imprecise, indicates an added value of trend analysis. This highlights the need for well-controlled trials to thoroughly assess the research question.
| S-EPMC6333367 | biostudies-literature
Project description:Continuous vital sign monitoring (CM) may detect ward patient's deterioration earlier than periodic monitoring. This could result in timely ICU transfers or in a transfer delay due to misperceived higher level of care on the ward. The primary objective of this study was to compare patient's disease severity upon unplanned ICU transfer, before and after CM implementation. We included a one-year period before and after CM implementation between August 1, 2017 - July 31, 2019. Before implementation, surgical and internal medicine patients' vital signs were periodically monitored, compared to continuous monitoring with wireless linkage to hospital systems after implementation. In both periods the same early warning score (EWS) protocol was in place. Primary outcome was disease severity scores upon ICU transfer. Secondary outcomes were ICU and hospital length of stay, incidence of mechanical ventilation and ICU mortality. In the two one-year periods 93 and 59 unplanned ICU transfer episodes were included, respectively. Median SOFA (3 (2-6) vs 4 (2-7), p = .574), APACHE II (17 (14-20) vs 16 (14-21), p = .824) and APACHE IV (59 (46-67) vs 50 (36-65), p = .187) were comparable between both periods, as were the median ICU LOS (3.0 (1.7-5.8) vs 3.1 (1.6-6.1), p.962), hospital LOS (23.6 (11.5-38.0) vs 19 (13.9-39.2), p = .880), incidence of mechanical ventilation (28 (47%) vs 22 (54%), p.490), and ICU mortality (11 (13%) vs 10 (19%), p.420). This study shows no difference in disease severity upon unplanned ICU transfer after CM implementation for patients who have deteriorated on the ward.
| S-EPMC10066074 | biostudies-literature
Project description:BackgroundHospital stays after colorectal surgery are increasingly being reduced by enhanced recovery and early discharge protocols. As a result, postoperative complications may frequently manifest after discharge in the home setting, potentially leading to emergency room presentations and readmissions. Virtual care interventions after hospital discharge may capture clinical deterioration at an early stage and hold promise for the prevention of readmissions and overall better outcomes. Recent technological advances have enabled continuous vital sign monitoring by wearable wireless sensor devices. However, the potential of these devices for virtual care interventions for patients discharged after colorectal surgery is currently unknown.ObjectiveWe aimed to determine the feasibility of a virtual care intervention consisting of continuous vital sign monitoring with wearable wireless sensors and teleconsultations for patients discharged after colorectal surgery.MethodsIn a single-center observational cohort study, patients were monitored at home for 5 consecutive days after discharge. Daily vital sign trend assessments and telephone consultations were performed by a remote patient-monitoring department. Intervention performance was evaluated by analyzing vital sign trend assessments and telephone consultation reports. Outcomes were categorized as "no concern," "slight concern," or "serious concern." Serious concern prompted contact with the surgeon on call. In addition, the quality of the vital sign data was determined, and the patient experience was evaluated.ResultsAmong 21 patients who participated in this study, 104 of 105 (99%) measurements of vital sign trends were successful. Of these 104 vital sign trend assessments, 68% (n=71) did not raise any concern, 16% (n=17) were unable to be assessed because of data loss, and none led to contacting the surgeon. Of 62 of 63 (98%) successfully performed telephone consultations, 53 (86%) did not raise any concerns and only 1 resulted in contacting the surgeon. A 68% agreement was found between vital sign trend assessments and telephone consultations. Overall completeness of the 2347 hours of vital sign trend data was 46.3% (range 5%-100%). Patient satisfaction score was 8 (IQR 7-9) of 10.ConclusionsA home monitoring intervention of patients discharged after colorectal surgery was found to be feasible, given its high performance and high patient acceptability. However, the intervention design needs further optimization before the true value of remote monitoring for early discharge protocols, prevention of readmissions, and overall patient outcomes can be adequately determined.
| S-EPMC10199380 | biostudies-literature