Surveillance of high-risk early postsurgical patients for real-time detection of complications using wireless monitoring (SHEPHERD study):results of a randomized multicenter stepped wedge cluster trial

Background: Vital signs measurements on the ward are performed intermittently. This could lead to failure to rapidly detect patients with deteriorating vital signs and worsens long-term outcome. The aim of this study was to test the hypothesis that continuous wireless monitoring of vital signs on the postsurgical ward improves patient outcome. Methods: In this prospective, multicenter, stepped-wedge cluster randomized study, patients in the control group received standard monitoring. The intervention group received continuous wireless monitoring of heart rate, respiratory rate and temperature on top of standard care. Automated alerts indicating vital signs deviation from baseline were sent to ward nurses, triggering the calculation of a full early warning score followed. The primary outcome was the occurrence of new disability three months after surgery. Results: The study was terminated early (at 57% inclusion) due to COVID-19 restrictions. Therefore, only descriptive statistics are presented. A total of 747 patients were enrolled in this study and eligible for statistical analyses, 517 patients in the control group and 230 patients in the intervention group, the latter only from one hospital. New disability at three months after surgery occurred in 43.7% in the control group and in 39.1% in the intervention group (absolute difference 4.6%). Conclusion: This is the largest randomized controlled trial investigating continuous wireless monitoring in postoperative patients. While patients in the intervention group seemed to experience less (new) disability than patients in the control group, results remain inconclusive with regard to postoperative patient outcome due to premature study termination. Clinical trial registration: ClinicalTrials.gov, ID: NCT02957825.</p

Plasma Transfusion and Procoagulant Product Administration in Extracorporeal Membrane Oxygenation:A Secondary Analysis of an International Observational Study on Current Practices

OBJECTIVES: To achieve optimal hemostatic balance in patients on extracorporeal membrane oxygenation (ECMO), a liberal transfusion practice is currently applied despite clear evidence. We aimed to give an overview of the current use of plasma, fibrinogen concentrate, tranexamic acid (TXA), and prothrombin complex concentrate (PCC) in patients on ECMO.DESIGN: A prespecified subanalysis of a multicenter retrospective study. Venovenous (VV)-ECMO and venoarterial (VA)-ECMO are analyzed as separate populations, comparing patients with and without bleeding and with and without thrombotic complications. SETTING: Sixteen international ICUs.PATIENTS: Adult patients on VA-ECMO or VV-ECMO.INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Of 420 VA-ECMO patients, 59% (n = 247) received plasma, 20% (n = 82) received fibrinogen concentrate, 17% (n = 70) received TXA, and 7% of patients (n = 28) received PCC. Fifty percent of patients (n = 208) suffered bleeding complications and 27% (n = 112) suffered thrombotic complications. More patients with bleeding complications than patients without bleeding complications received plasma (77% vs. 41%, p &lt; 0.001), fibrinogen concentrate (28% vs 11%, p &lt; 0.001), and TXA (23% vs 10%, p &lt; 0.001). More patients with than without thrombotic complications received TXA (24% vs 14%, p = 0.02, odds ratio 1.75) in VA-ECMO, where no difference was seen in VV-ECMO. Of 205 VV-ECMO patients, 40% (n = 81) received plasma, 6% (n = 12) fibrinogen concentrate, 7% (n = 14) TXA, and 5% (n = 10) PCC. Thirty-nine percent (n = 80) of VV-ECMO patients suffered bleeding complications and 23% (n = 48) of patients suffered thrombotic complications. More patients with than without bleeding complications received plasma (58% vs 28%, p &lt; 0.001), fibrinogen concentrate (13% vs 2%, p &lt; 0.01), and TXA (11% vs 2%, p &lt; 0.01). CONCLUSIONS: The majority of patients on ECMO receive transfusions of plasma, procoagulant products, or antifibrinolytics. In a significant part of the plasma transfused patients, this was in the absence of bleeding or prolonged international normalized ratio. This poses the question if these plasma transfusions were administered for another indication or could have been avoided.</p

Red blood cell transfusion in the intensive care unit

Importance Red blood cell (RBC) transfusion is common among patients admitted to the intensive care unit (ICU). Despite multiple randomized clinical trials of hemoglobin (Hb) thresholds for transfusion, little is known about how these thresholds are incorporated into current practice. Objective To evaluate and describe ICU RBC transfusion practices worldwide. Design, Setting, and Participants International, prospective, cohort study that involved 3643 adult patients from 233 ICUs in 30 countries on 6 continents from March 2019 to October 2022 with data collection in prespecified weeks. Exposure ICU stay. Main Outcomes and Measures The primary outcome was the occurrence of RBC transfusion during ICU stay. Additional outcomes included the indication(s) for RBC transfusion (consisting of clinical reasons and physiological triggers), the stated Hb threshold and actual measured Hb values before and after an RBC transfusion, and the number of units transfused. Results Among 3908 potentially eligible patients, 3643 were included across 233 ICUs (median of 11 patients per ICU [IQR, 5-20]) in 30 countries on 6 continents. Among the participants, the mean (SD) age was 61 (16) years, 62% were male (2267/3643), and the median Sequential Organ Failure Assessment score was 3.2 (IQR, 1.5-6.0). A total of 894 patients (25%) received 1 or more RBC transfusions during their ICU stay, with a median total of 2 units per patient (IQR, 1-4). The proportion of patients who received a transfusion ranged from 0% to 100% across centers, from 0% to 80% across countries, and from 19% to 45% across continents. Among the patients who received a transfusion, a total of 1727 RBC transfusions were administered, wherein the most common clinical indications were low Hb value (n = 1412 [81.8%]; mean [SD] lowest Hb before transfusion, 7.4 [1.2] g/dL), active bleeding (n = 479; 27.7%), and hemodynamic instability (n = 406 [23.5%]). Among the events with a stated physiological trigger, the most frequently stated triggers were hypotension (n = 728 [42.2%]), tachycardia (n = 474 [27.4%]), and increased lactate levels (n = 308 [17.8%]). The median lowest Hb level on days with an RBC transfusion ranged from 5.2 g/dL to 13.1 g/dL across centers, from 5.3 g/dL to 9.1 g/dL across countries, and from 7.2 g/dL to 8.7 g/dL across continents. Approximately 84% of ICUs administered transfusions to patients at a median Hb level greater than 7 g/dL. Conclusions and Relevance RBC transfusion was common in patients admitted to ICUs worldwide between 2019 and 2022, with high variability across centers in transfusion practices

Reducing postoperative fasting times by implementing a food service in the Post Anaesthesia Care Unit (PACU)

Background & aims: Early oral postoperative nutrition is a proven beneficial element of postoperative care, resulting in improvement in quality of life and a shorter hospital stay. Guidelines state that postoperative oral nutrition can safely be started within the first hours after surgery. However, oral nutrition is mainly investigated starting from postoperative day one (POD1). This pragmatic study assessed whether a food service in the Post Anaesthesia Care Unit (PACU) may reduce postoperative fasting times on postoperative day zero (POD0) early after surgery on this high care unit. The primary outcome was postoperative fasting time in the PACU. Secondary outcomes were postoperative patient experiences and nutritional tolerance. Methods: This pragmatic prospective before-after study, included adult patients with a planned overnight stay in the PACU, and without anticipated postoperative dietary restrictions. A food service was developed, allowing re-uptake of oral nutrition early after surgery, already at POD0. Postoperative fasting time in the PACU was defined as the duration of time between the moment of arrival at the PACU, until first postoperative intake or until 9 a.m. on POD1, when most patients were discharged to the surgical ward. Secondary outcomes such as postoperative patient experiences and nutritional tolerance were scored on POD0 at 8 p.m. and on POD1 at 8 a.m. Results: A total of 235 patients were included, 119 in the pre-implementation (control) and 116 in the post-implementation (intervention) group. Mean postoperative fasting time was reduced by a mean of 6.0 h (95% CI 4.8–7.4, p-value ≤ .001), from 17.5 h in controls to 11.5 h in the intervention group. In the intervention group, 45% of patients had nutritional intake on POD0 (8 p.m.), increasing to 80% of patients on POD1 (8 a.m.), compared to no intake at both time-points in the control group. In the intervention group, average patient satisfaction increased over time. Flatus frequency was higher in the intervention group on POD1 (45% vs. 22%, p-value ≤ .001), while postoperative nausea and/or vomiting, and usage of anti-emetic medication were not different between groups. Conclusions: In a heterogeneous group of adult post-surgical patients with a planned overnight stay in the PACU, implementation of a food service resulted in a significant and clinically relevant reduction of postoperative fasting time, and increased patient satisfaction without compromising nutritional tolerance. Registered at www.isrctn.org with study ID ISRCTN17976930

Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial

Importance: Intraoperative hypotension is associated with increased morbidity and mortality. A machine learning-derived early warning system to predict hypotension shortly before it occurs has been developed and validated. Objective: To test whether the clinical application of the early warning system in combination with a hemodynamic diagnostic guidance and treatment protocol reduces intraoperative hypotension. Design, Setting, and Participants: Preliminary unblinded randomized clinical trial performed in a tertiary center in Amsterdam, the Netherlands, among adult patients scheduled for elective noncardiac surgery under general anesthesia and an indication for continuous invasive blood pressure monitoring, who were enrolled between May 2018 and March 2019. Hypotension was defined as a mean arterial pressure (MAP) below 65 mm Hg for at least 1 minute. Interventions: Patients were randomly assigned to receive either the early warning system (n = 34) or standard care (n = 34), with a goal MAP of at least 65 mm Hg in both groups. Main Outcomes and Measures: The primary outcome was time-weighted average of hypotension during surgery, with a unit of measure of millimeters of mercury. This was calculated as the depth of hypotension below a MAP of 65 mm Hg (in millimeters of mercury) × time spent below a MAP of 65 mm Hg (in minutes) divided by total duration of operation (in minutes). Results: Among 68 randomized patients, 60 (88%) completed the trial (median age, 64 [interquartile range {IQR}, 57-70] years; 26 [43%] women). The median length of surgery was 256 minutes (IQR, 213-430 minutes). The median time-weighted average of hypotension was 0.10 mm Hg (IQR, 0.01-0.43 mm Hg) in the intervention group vs 0.44 mm Hg (IQR, 0.23-0.72 mm Hg) in the control group, for a median difference of 0.38 mm Hg (95% CI, 0.14-0.43 mm Hg; P = .001). The median time of hypotension per patient was 8.0 minutes (IQR, 1.33-26.00 minutes) in the intervention group vs 32.7 minutes (IQR, 11.5-59.7 minutes) in the control group, for a median difference of 16.7 minutes (95% CI, 7.7-31.0 minutes; P < .001). In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group. Conclusions and Relevance: In this single-center preliminary study of patients undergoing elective noncardiac surgery, the use of a machine learning-derived early warning system compared with standard care resulted in less intraoperative hypotension. Further research with larger study populations in diverse settings is needed to understand the effect on additional patient outcomes and to fully assess safety and generalizability. Trial Registration: ClinicalTrials.gov Identifier: NCT03376347

Effect of Hypotension Prediction Index-guided intraoperative haemodynamic care on depth and duration of postoperative hypotension: a sub-study of the Hypotension Prediction trial

Background: Intraoperative and postoperative hypotension are associated with morbidity and mortality. The Hypotension Prediction (HYPE) trial showed that the Hypotension Prediction Index (HPI) reduced the depth and duration of intraoperative hypotension (IOH), without excess use of intravenous fluid, vasopressor, and/or inotropic therapies. We hypothesised that intraoperative HPI-guided haemodynamic care would reduce the severity of postoperative hypotension in the PACU. Methods: This was a sub-study of the HYPE study, in which 60 adults undergoing elective noncardiac surgery were allocated randomly to intraoperative HPI-guided or standard haemodynamic care. Blood pressure was measured using a radial intra-arterial catheter, which was connected to a FloTracIQ sensor. Hypotension was defined as MAP <65 mm Hg, and a hypotensive event was defined as MAP <65 mm Hg for at least 1 min. The primary outcome was the time-weighted average (TWA) of postoperative hypotension. Secondary outcomes were absolute incidence, area under threshold for hypotension, and percentage of time spent with MAP <65 mm Hg. Results: Overall, 54/60 (90%) subjects (age 64 (8) yr; 44% female) completed the protocol, owing to failure of the FloTracIQ device in 6/60 (10%) patients. Intraoperative HPI-guided care was used in 28 subjects; 26 subjects were randomised to the control group. Postoperative hypotension occurred in 37/54 (68%) subjects. HPI-guided care did not reduce the median duration (TWA) of postoperative hypotension (adjusted median difference, vs standard of care: 0.118; 95% confidence interval [CI], 0–0.332; P=0.112). HPI-guidance reduced the percentage of time with MAP <65 mm Hg by 4.9% (adjusted median difference: –4.9; 95% CI, –11.7 to –0.01; P=0.046). Conclusions: Intraoperative HPI-guided haemodynamic care did not reduce the TWA of postoperative hypotension

Performance of a Machine Learning Algorithm to Predict Hypotension in Spontaneously Breathing Non-Ventilated Post-Anesthesia and ICU Patients

Background: Hypotension is common in the post-anesthesia care unit (PACU) and intensive care unit (ICU), and is associated with adverse patient outcomes. The Hypotension Prediction Index (HPI) algorithm has been shown to accurately predict hypotension in mechanically ventilated patients in the OR and ICU and to reduce intraoperative hypotension (IOH). Since positive pressure ventilation significantly affects patient hemodynamics, we performed this validation study to examine the performance of the HPI algorithm in a non-ventilated PACU and ICU population. Materials & Methods: The performance of the HPI algorithm was assessed using prospectively collected blood pressure (BP) and HPI data from a PACU and a mixed ICU population. Recordings with sufficient time (≥3 h) spent without mechanical ventilation were selected using data from the electronic medical record. All HPI values were evaluated for sensitivity, specificity, predictive value, and time-to-event, and a receiver operating characteristic (ROC) curve was constructed. Results: BP and HPI data from 282 patients were eligible for analysis, of which 242 (86%) were ICU patients. The mean age (standard deviation) was 63 (13.5) years, and 186 (66%) of the patients were male. Overall, the HPI predicted hypotension accurately, with an area under the ROC curve of 0.94. The most used HPI threshold cutoff in research and clinical use, 85, showed a sensitivity of 1.00, specificity of 0.79, median time-to-event of 160 s [60–380], PPV of 0.85, and NPV of 1.00. Conclusion: The absence of positive pressure ventilation and the influence thereof on patient hemodynamics does not negatively affect the performance of the HPI algorithm in predicting hypotension in the PACU and ICU. Future research should evaluate the feasibility and influence on hypotension and outcomes following HPI implementation in non-ventilated patients at risk of hypotension

Immediate reduction in left ventricular ejection time following TAVI is associated with improved quality of life

Background: TAVI has shown to result in immediate and sustained hemodynamic alterations and improvement in health-related quality of life (HRQoL), but previous studies have been suboptimal to predict who might benefit from TAVI. The relationship between immediate hemodynamic changes and outcome has not been studied before. This study sought to assess whether an immediate hemodynamic change, reflecting myocardial contractile reserve, following TAVI is associated with improved HRQoL. Furthermore, it assessed whether pre-procedural cardiac power index (CPI) and left ventricular ejection fraction (LVEF) could predict these changes. Methods: During the TAVI procedure, blood pressure and systemic hemodynamics were prospectively collected with a Nexfin ® non-invasive monitor. HRQoL was evaluated pre-procedurally and 12 weeks after the procedure, using the EQ-5D-5L classification tool. Results: Overall, 97/114 (85%) of the included patients were eligible for analyses. Systolic, diastolic and mean arterial pressure, heart rate, and stroke volume increased immediately after TAVI (all p < 0.005), and left ventricular ejection time (LVET) immediately decreased with 10 ms (95%CI = −4 to −16, p < 0.001). Overall HRQoL index increased from 0.810 [0.662–0.914] before to 0.887 [0.718–0.953] after TAVI (p = 0.016). An immediate decrease in LVET was associated with an increase in HRQoL index (0.02 index points per 10 ms LVET decrease, p = 0.041). Pre-procedural CPI and LVEF did not predict hemodynamic changes or change in HRQoL. Conclusion: TAVI resulted in an immediate hemodynamic response and increase in HRQoL. Immediate reduction in LVET, suggesting unloading of the ventricle, was associated with an increase in HRQoL, but neither pre-procedural CPI nor LVEF predicted these changes. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT0308878

Immediate reduction in left ventricular ejection time following TAVI is associated with improved quality of life

Background: TAVI has shown to result in immediate and sustained hemodynamic alterations and improvement in health-related quality of life (HRQoL), but previous studies have been suboptimal to predict who might benefit from TAVI. The relationship between immediate hemodynamic changes and outcome has not been studied before. This study sought to assess whether an immediate hemodynamic change, reflecting myocardial contractile reserve, following TAVI is associated with improved HRQoL. Furthermore, it assessed whether pre-procedural cardiac power index (CPI) and left ventricular ejection fraction (LVEF) could predict these changes. Methods: During the TAVI procedure, blood pressure and systemic hemodynamics were prospectively collected with a Nexfin® non-invasive monitor. HRQoL was evaluated pre-procedurally and 12 weeks after the procedure, using the EQ-5D-5L classification tool. Results: Overall, 97/114 (85%) of the included patients were eligible for analyses. Systolic, diastolic and mean arterial pressure, heart rate, and stroke volume increased immediately after TAVI (all p < 0.005), and left ventricular ejection time (LVET) immediately decreased with 10 ms (95%CI = −4 to −16, p < 0.001). Overall HRQoLindex increased from 0.810 [0.662–0.914] before to 0.887 [0.718–0.953] after TAVI (p = 0.016). An immediate decrease in LVET was associated with an increase in HRQoLindex (0.02 index points per 10 ms LVET decrease, p = 0.041). Pre-procedural CPI and LVEF did not predict hemodynamic changes or change in HRQoL. Conclusion: TAVI resulted in an immediate hemodynamic response and increase in HRQoL. Immediate reduction in LVET, suggesting unloading of the ventricle, was associated with an increase in HRQoL, but neither pre-procedural CPI nor LVEF predicted these changes. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT0308878