Designing a Virtual Hospital-at-Home Intervention for Patients with Infectious Diseases: A Data-Driven Approach.

BACKGROUND: Virtual hospital-at-home care might be an alternative to standard hospital care for patients with infectious diseases. In this study, we explore the potential for virtual hospital-at-home care and a potential design for this population. METHODS: This was a retrospective cohort study of internal medicine patients suspected of infectious diseases, admitted between 1 January and 31 December 2019. We collected information on delivered care during emergency department visits, the first 24 h, between 24 and 72 h, and after 72 h of admission. Care components that could be delivered at home were combined into care packages, and the potential number of eligible patients per package was described. The most feasible package was described in detail. RESULTS: 763 patients were included, mostly referred for general internal medicine (35%), and the most common diagnosis was lower respiratory tract infection (27%). The most frequently administered care components were laboratory tests, non-oral medication, and intercollegiate consultation. With a combination of telemonitoring, video consultation, non-oral medication administration, laboratory tests, oxygen therapy, and radiological diagnostics, 48% of patients were eligible for hospital-at-home care, with 35% already eligible directly after emergency department visits. CONCLUSION: While the potential for virtual hospital-at-home care is high, it depends greatly on which care can be arranged.

Interpretation of continuously measured vital signs data of COVID-19 patients by nurses and physicians at the general ward: A mixed methods study.

BACKGROUND: Continuous monitoring of vital signs is introduced at general hospital wards to detect patient deterioration. Interpretation and response currently rely on experience and expert opinion. This study aims to determine whether consensus exist among hospital professionals regarding the interpretation of vital signs of COVID-19 patients. In addition, we assessed the ability to recognise respiratory insufficiency and evaluated the interpretation process. METHODS: We performed a mixed methods study including 24 hospital professionals (6 nurses, 6 junior physicians, 6 internal medicine specialists, 6 ICU nurses). Each participant was presented with 20 cases of COVID-19 patients, including 4 or 8 hours of continuously measured vital signs data. Participants estimated the patient's situation ('improving', 'stable', or 'deteriorating') and the possibility of developing respiratory insufficiency. Subsequently, a semi-structured interview was held focussing on the interpretation process. Consensus was assessed using Krippendorff's alpha. For the estimation of respiratory insufficiency, we calculated the mean positive/negative predictive value. Interviews were analysed using inductive thematic analysis. RESULTS: We found no consensus regarding the patient's situation (α 0.41, 95%CI 0.29-0.52). The mean positive predictive value for respiratory insufficiency was high (0.91, 95%CI 0.86-0.97), but the negative predictive value was 0.66 (95%CI 0.44-0.88). In the interviews, two themes regarding the interpretation process emerged. "Interpretation of deviations" included the strategies participants use to determine stability, focused on finding deviations in data. "Inability to see the patient" entailed the need of hospital professionals to perform a patient evaluation when estimating a patient's situation. CONCLUSION: The interpretation of continuously measured vital signs by hospital professionals, and recognition of respiratory insufficiency using these data, is variable, which might be the result of different interpretation strategies, uncertainty regarding deviations, and not being able to see the patient. Protocols and training could help to uniform interpretation, but decision support systems might be necessary to find signs of deterioration that might otherwise go unnoticed.

Age-Stratified Propofol Dosage for Pediatric Procedural Sedation and Analgesia.

BACKGROUND: Procedural sedation and analgesia (PSA) for diagnostic and minimally invasive therapeutic procedures has become common practice in children of all ages. Based on our clinical experience, we suspected an inverse relation between age and dosage. However, a schedule for age-stratified propofol induction and maintenance dosage for PSA was not available and could be helpful to many anesthesiologists as a reference. METHODS: We performed a retrospective cohort study of children who received procedural sedation at the Wilhelmina Children's Hospital (WKZ), a tertiary pediatric hospital part of the University Medical Center Utrecht (UMCU), between June 2007 and December 2020. We studied whether the induction (mg·kg -1 ) and maintenance (mg·kg -1 ·h -1 ) dosage is age-dependent using linear regression models. RESULTS: A total of 6438 pediatric procedures were retrieved from Anesthesia Information Management Systems (AIMS). A total of 5567 records were available for induction dose analysis and 5420 records for analysis of the maintenance dose. After adjustment for sex, American Society of Anesthesiologists (ASA) physical status classification, opioid administration, and diagnostic or interventional, we obtained a coefficient of -0.11 (95% confidence interval [CI], -0.12 to -0.11) for age (years) from a multivariable linear regression model for propofol induction dosage (mg·kg -1 ) and a coefficient of -0.36 (95% CI, -0.39 to -0.34) for age (years) for propofol maintenance dosage. CONCLUSIONS: We found a noteworthy inverse age-effect on propofol dosage for both induction and maintenance of pediatric procedural sedation. Furthermore, our study revealed that remarkably higher propofol sedation doses were needed for infants and toddlers than previously expected and reported.

Association of Continuously Measured Vital Signs With Respiratory Insufficiency in Hospitalized COVID-19 Patients: Retrospective Cohort Study.

BACKGROUND: Continuous monitoring of vital signs has the potential to assist in the recognition of deterioration of patients admitted to the general ward. However, methods to efficiently process and use continuously measured vital sign data remain unclear. OBJECTIVE: The aim of this study was to explore methods to summarize continuously measured vital sign data and evaluate their association with respiratory insufficiency in COVID-19 patients at the general ward. METHODS: In this retrospective cohort study, we included patients admitted to a designated COVID-19 cohort ward equipped with continuous vital sign monitoring. We collected continuously measured data of respiratory rate, heart rate, and oxygen saturation. For each patient, 7 metrics to summarize vital sign data were calculated: mean, slope, variance, occurrence of a threshold breach, number of episodes, total duration, and area above/under a threshold. These summary measures were calculated over timeframes of either 4 or 8 hours, with a pause between the last data point and the endpoint (the "lead") of 4, 2, 1, or 0 hours, and with 3 predefined thresholds per vital sign. The association between each of the summary measures and the occurrence of respiratory insufficiency was calculated using logistic regression analysis. RESULTS: Of the 429 patients that were monitored, 334 were included for analysis. Of these, 66 (19.8%) patients developed respiratory insufficiency. Summarized continuously measured vital sign data in timeframes close to the endpoint showed stronger associations than data measured further in the past (ie, lead 0 vs 1, 2, or 4 hours), and summarized estimates over 4 hours of data had stronger associations than estimates taken over 8 hours of data. The mean was consistently strongly associated with respiratory insufficiency for the three vital signs: in a 4-hour timeframe without a lead, the standardized odds ratio for heart rate, respiratory rate, and oxygen saturation was 2.59 (99% CI 1.74-4.04), 5.05 (99% CI 2.87-10.03), and 3.16 (99% CI 1.78-6.26), respectively. The strength of associations of summary measures varied per vital sign, timeframe, and lead. CONCLUSIONS: The mean of a vital sign showed a relatively strong association with respiratory insufficiency for the majority of vital signs and timeframes. The type of vital sign, length of the timeframe, and length of the lead influenced the strength of associations. Highly associated summary measures and their combinations could be used in a clinical prediction score or algorithm for an automatic alarm system.

Definitions of low cardiac output syndrome after cardiac surgery and their effect on the incidence of intraoperative LCOS: A literature review and cohort study.

Objectives: Low cardiac output syndrome (LCOS) is a serious complication after cardiac surgery. Despite scientific interest in LCOS, there is no uniform definition used in current research and clinicians cannot properly compare different study findings. We aimed to collect the LCOS definitions used in literature and subsequently applied the definitions obtained to existing data to estimate their effect on the intraoperative LCOS incidences in adults, children and infants. Design: This is a literature review, followed by a retrospective cohort study. Setting: This is a single-institutional study from a university hospital in the Netherlands. Participants: Patients from all ages undergoing cardiac surgery with cardiopulmonary bypass between June 2011 and August 2018. Interventions: We obtained different definitions of LCOS used in the literature and applied these to data obtained from an anesthesia information management system to estimate intraoperative incidences of LCOS. We compared intraoperative incidences of LCOS in different populations based on age (infants, children and adults). Measurements and main results: The literature search identified 262 LCOS definitions, that were applied to intraoperative data from 7,366 patients. Using the 10 most frequently published LCOS definitions, the obtained incidence estimates ranged from 0.4 to 82% in infants, from 0.6 to 56% in children and from 1.5 to 91% in adults. Conclusion: There is an important variety in definitions used to describe LCOS. When applied to data obtained from clinical care, these different definitions resulted in large distribution of intraoperative LCOS incidence rates. We therefore advocate for standardization of the LCOS definition to improve clinical understanding and enable adequate comparison of outcomes and treatment effects both in daily care and in research.

Early Determinants of Adverse Motor Outcomes in Preschool Children with a Critical Congenital Heart Defect.

Neurodevelopmental disabilities are common in infants with critical congenital heart disease (CCHD). A prospective, longitudinal cohort study was conducted to establish the prevalence and early determinants of adverse motor outcomes in infants who underwent cardiac surgery with cardiopulmonary bypass before six months of age. Motor development was assessed in 147 preschoolers using the Movement Assessment Battery for children-II. Although the majority displayed an average motor development, 22% of preschool children with CCHD deteriorated in their motor developmental score compared to their previous assessment at 18 months, especially in those with an aortic arch anomaly (AAA) (35%). Individual stability over time appeared to be moderate and the number of children with a motor delay increased, up to 20% in children with AAA. Motor development up to 42 months was best predicted by gestational age, cardio pulmonary bypass time, aortic cross clamp time, number of heart catheterizations up to 18 months and early motor outcomes. The increase in number of preschool children with a motor delay underlines the importance of longitudinal screening of motor skills in children with CCHD at risk for adverse motor outcomes. Offering early interventions may protect their current and future cardiovascular health as motor development is an independent predictor of exercise capacity, physical activity and participation in daily living.

Perioperative Management of an Adolescent Fontan Patient with Narrowing of the Aortopulmonary Space for Posterior Scoliosis Surgery.

Congenital cardiac patients who received neonatal reconstructive aortic arch surgery are at risk of aortopulmonary space narrowing with compression of the left pulmonary artery and left main bronchus (LMB) later in life. We discuss a challenging adolescent single ventricle patient who presented for surgical treatment of a non-idiopathic thoracic scoliosis (posterior spinal fusion) with severe stenosis of the LMB and left pulmonary artery due to a narrow aortopulmonary space. Careful preoperative imaging, evaluation, and decision making resulted in successful surgical treatment and uneventful perioperative course.

Circadian patterns of heart rate, respiratory rate and skin temperature in hospitalized COVID-19 patients.

RATIONALE: Vital signs follow circadian patterns in both healthy volunteers and critically ill patients, which seem to be influenced by disease severity in the latter. In this study we explored the existence of circadian patterns in heart rate, respiratory rate and skin temperature of hospitalized COVID-19 patients, and aimed to explore differences in circadian rhythm amplitude during patient deterioration. METHODS: We performed a retrospective study of COVID-19 patients admitted to the general ward of a tertiary hospital between April 2020 and March 2021. Patients were continuously monitored using a wireless sensor and fingertip pulse oximeter. Data was divided into three cohorts: patients who recovered, patients who developed respiratory insufficiency and patients who died. For each cohort, a population mean cosinor model was fitted to detect rhythmicity. To assess changes in amplitude, a mixed-effect cosinor model was fitted. RESULTS: A total of 429 patients were monitored. Rhythmicity was observed in heartrate for the recovery cohort (p<0.001), respiratory insufficiency cohort (p<0.001 and mortality cohort (p = 0.002). Respiratory rate showed rhythmicity in the recovery cohort (p<0.001), but not in the other cohorts (p = 0.18 and p = 0.51). Skin temperature also showed rhythmicity in the recovery cohort (p<0.001), but not in the other cohorts (p = 0.22 and p = 0.12). For respiratory insufficiency, only the amplitude of heart rate circadian pattern increased slightly the day before (1.2 (99%CI 0.16-2.2, p = 0.002)). In the mortality cohort, the amplitude of heart rate decreased (-1.5 (99%CI -2.6- -0.42, p<0.001)) and respiratory rate amplitude increased (0.72 (99%CI 0.27-1.3, p = 0.002) the days before death. CONCLUSION: A circadian rhythm is present in heart rate of COVID-19 patients admitted to the general ward. For respiratory rate and skin temperature, rhythmicity was only found in patients who recover, but not in patients developing respiratory insufficiency or death. We found no consistent changes in circadian rhythm amplitude accompanying patient deterioration.

Effect of Nitric Oxide via Cardiopulmonary Bypass on Ventilator-Free Days in Young Children Undergoing Congenital Heart Disease Surgery: The NITRIC Randomized Clinical Trial.

Importance: In children undergoing heart surgery, nitric oxide administered into the gas flow of the cardiopulmonary bypass oxygenator may reduce postoperative low cardiac output syndrome, leading to improved recovery and shorter duration of respiratory support. It remains uncertain whether nitric oxide administered into the cardiopulmonary bypass oxygenator improves ventilator-free days (days alive and free from mechanical ventilation). Objective: To determine the effect of nitric oxide applied into the cardiopulmonary bypass oxygenator vs standard care on ventilator-free days in children undergoing surgery for congenital heart disease. Design, Setting, and Participants: Double-blind, multicenter, randomized clinical trial in 6 pediatric cardiac surgical centers in Australia, New Zealand, and the Netherlands. A total of 1371 children younger than 2 years undergoing congenital heart surgery were randomized between July 2017 and April 2021, with 28-day follow-up of the last participant completed on May 24, 2021. Interventions: Patients were assigned to receive nitric oxide at 20 ppm delivered into the cardiopulmonary bypass oxygenator (n = 679) or standard care cardiopulmonary bypass without nitric oxide (n = 685). Main Outcomes and Measures: The primary end point was the number of ventilator-free days from commencement of bypass until day 28. There were 4 secondary end points including a composite of low cardiac output syndrome, extracorporeal life support, or death; length of stay in the intensive care unit; length of stay in the hospital; and postoperative troponin levels. Results: Among 1371 patients who were randomized (mean [SD] age, 21.2 [23.5] weeks; 587 girls [42.8%]), 1364 (99.5%) completed the trial. The number of ventilator-free days did not differ significantly between the nitric oxide and standard care groups, with a median of 26.6 days (IQR, 24.4 to 27.4) vs 26.4 days (IQR, 24.0 to 27.2), respectively, for an absolute difference of -0.01 days (95% CI, -0.25 to 0.22; P = .92). A total of 22.5% of the nitric oxide group and 20.9% of the standard care group developed low cardiac output syndrome within 48 hours, needed extracorporeal support within 48 hours, or died by day 28, for an adjusted odds ratio of 1.12 (95% CI, 0.85 to 1.47). Other secondary outcomes were not significantly different between the groups. Conclusions and Relevance: In children younger than 2 years undergoing cardiopulmonary bypass surgery for congenital heart disease, the use of nitric oxide via cardiopulmonary bypass did not significantly affect the number of ventilator-free days. These findings do not support the use of nitric oxide delivered into the cardiopulmonary bypass oxygenator during heart surgery. Trial Registration: anzctr.org.au Identifier: ACTRN12617000821392.

Remote Hospital Care for Recovering COVID-19 Patients Using Telemedicine: A Randomised Controlled Trial.

BACKGROUND: To ensure availability of hospital beds and improve COVID-19 patients' well-being during the ongoing pandemic, hospital care could be offered at home. Retrospective studies show promising results of deploying remote hospital care to reduce the number of days spent in the hospital, but the beneficial effect has yet to be established. METHODS: We conducted a single centre, randomised trial from January to June 2021, including hospitalised COVID-19 patients who were in the recovery stage of the disease. Hospital care for the intervention group was transitioned to the patient's home, including oxygen therapy, medication and remote monitoring. The control group received in-hospital care as usual. The primary endpoint was the number of hospital-free days during the 30 days following randomisation. Secondary endpoints included health care consumption during the follow-up period and mortality. RESULTS: A total of 62 patients were randomised (31 control, 31 intervention). The mean difference in hospital-free days was 1.7 (26.7 control vs. 28.4 intervention, 95% CI of difference -0.5 to 4.2, p = 0.112). In the intervention group, the index hospital length of stay was 1.6 days shorter (95% CI -2.4 to -0.8, p < 0.001), but the total duration of care under hospital responsibility was 4.1 days longer (95% CI 0.5 to 7.7, p = 0.028). CONCLUSION: Remote hospital care for recovering COVID-19 patients is feasible. However, we could not demonstrate an increase in hospital-free days in the 30 days following randomisation. Optimising the intervention, timing, and identification of patients who will benefit most from remote hospital care could improve the impact of this intervention.

Statistical analysis plan for the NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) trial.

Background: The NITric oxide during cardiopulmonary bypass (CPB) to improve Recovery in Infants with Congenital heart defects (NITRIC) trial, a 1320-patient, multicentre, randomised controlled trial, is aiming to improve survival free of ventilation after CPB by using nitric oxide delivered into the oxygenator of the CPB. Objective: To provide a statistical analysis plan before completion of patient recruitment and data monitoring. Final analyses for this study will adhere to this statistical analysis plan, which details all key pre-planned analyses. Stata scripts for analyses have been prepared alongside this statistical analysis plan. Methods: The statistical analysis plan was designed collaboratively by the chief investigators and trial statistician and builds on the previously published study protocol. All authors remain blinded to treatment allocation. Detail is provided on statistical analyses including cohort description, analysis of primary and secondary outcomes and adverse events. Statistical methods to compare outcomes are planned in detail to ensure methods are verifiable and reproducible. Results: The statistical analysis plan developed provides the trial outline, list of mock tables, and analysis scripts. The plan describes statistical analyses on cohort and baseline description, primary and secondary outcome analyses, process of care measures, physiological descriptors, and safety and adverse event reporting. We define the pre-specified subgroup analyses and the respective statistical tests used to compare subgroups. Conclusion: The statistical analysis plan for the NITRIC trial establishes detailed pre-planned analyses alongside Stata scripts to analyse the largest trial in the field of neonatal and paediatric heart surgery. The plan ensures standards for trial analysis validity aiming to minimise bias of analyses. Trial registration: ACTRN12617000821392.

Vital Signs Monitoring with Wearable Sensors in High-risk Surgical Patients: A Clinical Validation Study.

BACKGROUND: Vital signs are usually recorded once every 8 h in patients at the hospital ward. Early signs of deterioration may therefore be missed. Wireless sensors have been developed that may capture patient deterioration earlier. The objective of this study was to determine whether two wearable patch sensors (SensiumVitals [Sensium Healthcare Ltd., United Kingdom] and HealthPatch [VitalConnect, USA]), a bed-based system (EarlySense [EarlySense Ltd., Israel]), and a patient-worn monitor (Masimo Radius-7 [Masimo Corporation, USA]) can reliably measure heart rate (HR) and respiratory rate (RR) continuously in patients recovering from major surgery. METHODS: In an observational method comparison study, HR and RR of high-risk surgical patients admitted to a step-down unit were simultaneously recorded with the devices under test and compared with an intensive care unit-grade monitoring system (XPREZZON [Spacelabs Healthcare, USA]) until transition to the ward. Outcome measures were 95% limits of agreement and bias. Clarke Error Grid analysis was performed to assess the ability to assist with correct treatment decisions. In addition, data loss and duration of data gaps were analyzed. RESULTS: Twenty-five high-risk surgical patients were included. More than 700 h of data were available for analysis. For HR, bias and limits of agreement were 1.0 (-6.3, 8.4), 1.3 (-0.5, 3.3), -1.4 (-5.1, 2.3), and -0.4 (-4.0, 3.1) for SensiumVitals, HealthPatch, EarlySense, and Masimo, respectively. For RR, these values were -0.8 (-7.4, 5.6), 0.4 (-3.9, 4.7), and 0.2 (-4.7, 4.4) respectively. HealthPatch overestimated RR, with a bias of 4.4 (limits: -4.4 to 13.3) breaths/minute. Data loss from wireless transmission varied from 13% (83 of 633 h) to 34% (122 of 360 h) for RR and 6% (47 of 727 h) to 27% (182 of 664 h) for HR. CONCLUSIONS: All sensors were highly accurate for HR. For RR, the EarlySense, SensiumVitals sensor, and Masimo Radius-7 were reasonably accurate for RR. The accuracy for RR of the HealthPatch sensor was outside acceptable limits. Trend monitoring with wearable sensors could be valuable to timely detect patient deterioration.

Study protocol: NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC trial): a randomised controlled trial.

INTRODUCTION: Congenital heart disease (CHD) is a major cause of infant mortality. Many infants with CHD require corrective surgery with most operations requiring cardiopulmonary bypass (CPB). CPB triggers a systemic inflammatory response which is associated with low cardiac output syndrome (LCOS), postoperative morbidity and mortality. Delivery of nitric oxide (NO) into CPB circuits can provide myocardial protection and reduce bypass-induced inflammation, leading to less LCOS and improved recovery. We hypothesised that using NO during CPB increases ventilator-free days (VFD) (the number of days patients spend alive and free from invasive mechanical ventilation up until day 28) compared with standard care. Here, we describe the NITRIC trial protocol. METHODS AND ANALYSIS: The NITRIC trial is a randomised, double-blind, controlled, parallel-group, two-sided superiority trial to be conducted in six paediatric cardiac surgical centres. One thousand three-hundred and twenty infants <2 years of age undergoing cardiac surgery with CPB will be randomly assigned to NO at 20 ppm administered into the CPB oxygenator for the duration of CPB or standard care (no NO) in a 1:1 ratio with stratification by age (<6 and ≥6 weeks), single ventricle physiology (Y/N) and study centre. The primary outcome will be VFD to day 28. Secondary outcomes include a composite of LCOS, need for extracorporeal membrane oxygenation or death within 28 days of surgery; length of stay in intensive care and in hospital; and, healthcare costs. Analyses will be conducted on an intention-to-treat basis. Preplanned secondary analyses will investigate the impact of NO on host inflammatory profiles postsurgery. ETHICS AND DISSEMINATION: The study has ethical approval (HREC/17/QRCH/43, dated 26 April 2017), is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12617000821392) and commenced recruitment in July 2017. The primary manuscript will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ACTRN12617000821392.

Postoperative cerebral oxygenation was not associated with new brain injury in infants with congenital heart disease.

OBJECTIVE: The aim of this study was to evaluate postoperative indices of cerebral oxygenation and autoregulation in infants with critical congenital heart disease in relation to new postoperative ischemic brain injury. METHODS: This prospective, clinical cohort included 77 infants with transposition of the great arteries (N = 19), left ventricular outflow tract obstruction (N = 30), and single ventricle physiology (N = 28) undergoing surgery at 30 days or less of life. Postoperative near-infrared spectroscopy and physiologic monitoring were applied to extract mean arterial blood pressure, regional cerebral oxygen saturation, fractional tissue oxygen extraction, and regional cerebral oxygen saturation mean arterial blood pressure correlation coefficient (≥0.5 considered sign of impaired cerebral autoregulation). New postoperative ischemic injury was defined as moderate-severe white matter injury or focal infarction on magnetic resonance imaging. Low cardiac output syndrome was measured as lactate greater than 4 mmol/L with pH less than 7.30. RESULTS: After surgery, regional cerebral oxygen saturation was decreased in all congenital heart disease groups with a notable increase in regional cerebral oxygen saturation between 6 and 12 hours after surgery, on average with a factor of 1.4 (range, 1.1-2.4). Both single ventricle physiology and postoperative low cardiac output syndrome were associated with lower regional cerebral oxygen saturation and increased time with correlation coefficient of 0.5 or greater. New postoperative ischemic injury was seen in 39 patients (53%) and equally distributed across congenital heart disease groups. Postoperative regional cerebral oxygen saturation, fractional tissue oxygen extraction, and correlation coefficient were not independently associated with new postoperative white matter injury or focal infarction (mixed-model analysis, all F > 0.12). CONCLUSIONS: Postoperative indices of cerebral oxygenation and cerebral autoregulation are not independent predictors of new ischemic brain injury in infants with critical congenital heart disease. Further exploration of the complex interplay among low regional cerebral oxygen saturation, low cardiac output syndrome, and heart defect is required to identify potential biomarkers enabling early intervention for ischemic brain injury.

Accuracy of remote continuous respiratory rate monitoring technologies intended for low care clinical settings: a prospective observational study.

PURPOSE: Altered respiratory rate (RR) has been identified as an important predictor of serious adverse events during hospitalization. Introduction of a well-tolerated continuous RR monitor could potentially reduce serious adverse events such as opioid-induced respiratory depression. The purpose of this study was to investigate the ability of different monitor devices to detect RR in low care clinical settings. METHODS: This was a prospective method-comparison study with a cross-sectional design. Thoracic impedance pneumography (IPG), frequency modulated continuous wave radar, and an acoustic breath sounds monitor were compared with the gold standard of capnography for their ability to detect RR in breaths per minute (breaths·min-1) in awake postoperative patients in the postanesthesia care unit. The Bland and Altman method for repeated measurements and mixed effect modelling was used to obtain bias and limits of agreement (LoA). Furthermore, the ability of the three devices to assist with correct treatment decisions was evaluated in Clarke Error Grids. RESULTS: Twenty patients were monitored for 1,203 min, with a median [interquartile range] of 61 [60-63] min per patient. The bias (98.9% LoA) were 0.1 (-7.9 to 7.9) breaths·min-1 for the acoustic monitor, -1.6 (-10.8 to 7.6) for the radar, and -1.9 (-13.1 to 9.2) for the IPG. The extent to which the monitors guided adequate or led to inadequate treatment decisions (determined by Clarke Error Grid analysis) differed significantly between the monitors (P = 0.011). Decisions were correct 96% of the time for acoustic, 95% of the time for radar, and 94% of the time for IPG monitoring devices. CONCLUSIONS: None of the studied devices (acoustic, IPG, and radar monitor) had LoA that were within our predefined (based on clinical judgement) limits of ± 2 breaths·min-1. The acoustic breath sound monitor predicted the correct treatment more often than the IPG and the radar device.

Reliability of wireless monitoring using a wearable patch sensor in high-risk surgical patients at a step-down unit in the Netherlands: a clinical validation study.

BACKGROUND AND OBJECTIVES: Intermittent vital signs measurements are the current standard on hospital wards, typically recorded once every 8 hours. Early signs of deterioration may therefore be missed. Recent innovations have resulted in 'wearable' sensors, which may capture patient deterioration at an earlier stage. The objective of this study was to determine whether a wireless 'patch' sensor is able to reliably measure respiratory and heart rate continuously in high-risk surgical patients. The secondary objective was to explore the potential of the wireless sensor to serve as a safety monitor. DESIGN: In an observational methods comparisons study, patients were measured with both the wireless sensor and bedside routine standard for at least 24 hours. SETTING: University teaching hospital, single centre. PARTICIPANTS: Twenty-five postoperative surgical patients admitted to a step-down unit. OUTCOME MEASURES: Primary outcome measures were limits of agreement and bias of heart rate and respiratory rate. Secondary outcome measures were sensor reliability, defined as time until first occurrence of data loss. RESULTS: 1568 hours of vital signs data were analysed. Bias and 95% limits of agreement for heart rate were -1.1 (-8.8 to 6.5) beats per minute. For respiration rate, bias was -2.3 breaths per minute with wide limits of agreement (-15.8 to 11.2 breaths per minute). Median filtering over a 15 min period improved limits of agreement of both respiration and heart rate. 63% of the measurements were performed without data loss greater than 2 min. Overall data loss was limited (6% of time). CONCLUSIONS: The wireless sensor is capable of accurately measuring heart rate, but accuracy for respiratory rate was outside acceptable limits. Remote monitoring has the potential to contribute to early recognition of physiological decline in high-risk patients. Future studies should focus on the ability to detect patient deterioration on low care environments and at home after discharge.

Barriers and facilitators perceived by physicians when using prediction models in practice.

OBJECTIVES: Prediction models may facilitate risk-based management of health care conditions. In a large cluster-randomized trial, presenting calculated risks of postoperative nausea and vomiting (PONV) to physicians (assistive approach) increased risk-based management of PONV. This increase did not improve patient outcome-that is, PONV incidence. This prompted us to explore how prediction tools guide the decision-making process of physicians. STUDY DESIGN AND SETTING: Using mixed methods, we interviewed eight physicians to understand how predicted risks were perceived by the physicians and how they influenced decision making. Subsequently, all 57 physicians of the trial were surveyed for how the presented risks influenced their perceptions. RESULTS: Although the prediction tool made physicians more aware of PONV prevention, the physicians reported three barriers to use predicted risks in their decision making. PONV was not considered an outcome of utmost importance; decision making on PONV prophylaxis was mostly intuitive rather than risk based; prediction models do not weigh benefits and risks of prophylactic drugs. CONCLUSION: Combining probabilistic output of the model with their clinical experience may be difficult for physicians, especially when their decision-making process is mostly intuitive. Adding recommendations to predicted risks (directive approach) was considered an important step to facilitate the uptake of a prediction tool.

Non-Invasive Continuous Respiratory Monitoring on General Hospital Wards: A Systematic Review.

BACKGROUND: Failure to recognize acute deterioration in hospitalized patients may contribute to cardiopulmonary arrest, unscheduled intensive care unit admission and increased mortality. PURPOSE: In this systematic review we aimed to determine whether continuous non-invasive respiratory monitoring improves early diagnosis of patient deterioration and reduces critical incidents on hospital wards. DATA SOURCES: Studies were retrieved from Medline, Embase, CINAHL, and the Cochrane library, searched from 1970 till October 25, 2014. STUDY SELECTION: Electronic databases were searched using keywords and corresponding synonyms 'ward', 'continuous', 'monitoring' and 'respiration'. Pediatric, fetal and animal studies were excluded. DATA EXTRACTION: Since no validated tool is currently available for diagnostic or intervention studies with continuous monitoring, methodological quality was assessed with a modified tool based on modified STARD, CONSORT, and TREND statements. DATA SYNTHESIS: Six intervention and five diagnostic studies were included, evaluating the use of eight different devices for continuous respiratory monitoring. Quantitative data synthesis was not possible because intervention, study design and outcomes differed considerably between studies. Outcomes estimates for the intervention studies ranged from RR 0.14 (0.03, 0.64) for cardiopulmonary resuscitation to RR 1.00 (0.41, 2.35) for unplanned ICU admission after introduction of continuous respiratory monitoring. LIMITATIONS: The methodological quality of most studies was moderate, e.g. 'before-after' designs, incomplete reporting of primary outcomes, and incomplete clinical implementation of the monitoring system. CONCLUSIONS: Based on the findings of this systematic review, implementation of routine continuous non-invasive respiratory monitoring on general hospital wards cannot yet be advocated as results are inconclusive, and methodological quality of the studies needs improvement. Future research in this area should focus on technology explicitly suitable for low care settings and tailored alarm and treatment algorithms.

Capnography during deep sedation with propofol by nonanesthesiologists: a randomized controlled trial.

BACKGROUND: Propofol, a short-acting hypnotic drug, is increasingly administered by a diverse group of specialists (e.g., cardiologists, gastroenterologists) during diagnostic and therapeutic procedures. Standard monitoring during sedation comprises continuous pulse oximetry with visual assessment of the patient's breathing pattern. Because undetected hypoventilation is a common pathway for complications, capnographic monitoring of exhaled carbon dioxide has been advocated. We examined whether the use of capnography reduces the incidence of hypoxemia during nonanesthesiologist-administered propofol sedation in patients who did not receive supplemental oxygen routinely. METHODS: An open, stratified, randomized controlled trial was conducted in 427 healthy adult women during minor gynecology procedures in an outpatient clinic in the Netherlands. Patients were randomly assigned to receive either standard respiratory monitoring (standard care) or standard respiratory monitoring combined with capnography (capnography group). To replicate usual clinical practice, capnography monitoring was performed by the same medical team that provided sedation. The primary end point was the incidence of hypoxemia, defined as oxygen saturations <91%. RESULTS: From April 2010 to January 2011, 427 patients were enrolled. In the capnography group, 206 patients and in the standard care group, 209 patients were analyzed. The percentage of patients with a hypoxemic episode was 25.7% (53 of 206) in the capnography group and 24.9% (52 of 209) in the standard care group, resulting in an absolute difference of 0.8% (-7.5 to 9.2%). CONCLUSIONS: We were unable to confirm an additive role for capnography in preventing hypoxemia during elective nonanesthesiologist-administered propofol (monotherapy) sedation in healthy women in whom supplemental oxygen is not routinely administered. Based on the confidence interval, the benefit of adding capnography is at most an absolute hypoxemia reduction of 7.5%, suggesting that adding it in this practice setting to the routine monitoring strategy does not necessarily improve patient safety in daily practice.