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

Adaptive threshold-based alarm strategies for continuous vital signs monitoring

Continuous vital signs monitoring in post-surgical ward patients may support early detection of clinical deterioration, but novel alarm approaches are required to ensure timely notification of abnormalities and prevent alarm-fatigue. The current study explored the performance of classical and various adaptive threshold-based alarm strategies to warn for vital sign abnormalities observed during development of an adverse event. A classical threshold-based alarm strategy used for continuous vital signs monitoring in surgical ward patients was evaluated retrospectively. Next, (combinations of) six methods to adapt alarm thresholds to personal or situational factors were simulated in the same dataset. Alarm performance was assessed using the overall alarm rate and sensitivity to detect adverse events. Using a wireless patch-based monitoring system, 3999 h of vital signs data was obtained in 39 patients. The clinically used classical alarm system produced 0.49 alarms/patient/day, and alarms were generated for 11 out of 18 observed adverse events. Each of the tested adaptive strategies either increased sensitivity to detect adverse events or reduced overall alarm rate. Combining specific strategies improved overall performance most and resulted in earlier presentation of alarms in case of adverse events. Strategies that adapt vital sign alarm thresholds to personal or situational factors may improve early detection of adverse events or reduce alarm rates as compared to classical alarm strategies. Accordingly, further investigation of the potential of adaptive alarms for continuous vital signs monitoring in ward patients is warranted

Bihormonal Artificial Pancreas with Closed-Loop Glucose Control vs Current Diabetes Care after Total Pancreatectomy: A Randomized Clinical Trial

Importance: Glucose control in patients after total pancreatectomy is problematic because of the complete absence of α- and β-cells, leading to impaired quality of life. A novel, bihormonal artificial pancreas (BIHAP), using both insulin and glucagon, may improve glucose control, but studies in this setting are lacking. Objective: To assess the efficacy and safety of the BIHAP in patients after total pancreatectomy. Design, Setting, and Participants: This randomized crossover clinical trial compared the fully closed-loop BIHAP with current diabetes care (ie, insulin pump or pen therapy) in 12 adult outpatients after total pancreatectomy. Patients were recruited between August 21 and November 16, 2020. This first-in-patient study began with a feasibility phase in 2 patients. Subsequently, 12 patients were randomly assigned to 7-day treatment with the BIHAP (preceded by a 5-day training period) followed by 7-day treatment with current diabetes care, or the same treatments in reverse order. Statistical analysis was by Wilcoxon signed rank and Mann-Whitney U tests, with significance set at a 2-sided P <.05. Main Outcomes and Measures: The primary outcome was the percentage of time spent in euglycemia (70-180 mg/dL [3.9-10 mmol/L]) as assessed by continuous glucose monitoring. Results: In total, 12 patients (7 men and 3 women; median [IQR] age, 62.5 [43.1-74.0] years) were randomly assigned, of whom 3 did not complete the BIHAP phase and 1 was replaced. The time spent in euglycemia was significantly higher during treatment with the BIHAP (median, 78.30%; IQR, 71.05%-82.61%) than current diabetes care (median, 57.38%; IQR, 52.38%-81.35%; P =.03). In addition, the time spent in hypoglycemia (<70 mg/dL [3.9 mmol/L]) was lower with the BIHAP (median, 0.00% [IQR, 0.00%-0.07%] vs 1.61% [IQR, 0.80%-3.81%]; P =.004). No serious adverse events occurred. Conclusions and Relevance: Patients using the BIHAP after total pancreatectomy experienced an increased percentage of time in euglycemia and a reduced percentage of time in hypoglycemia compared with current diabetes care, without apparent safety risks. Larger randomized trials, including longer periods of treatment and an assessment of quality of life, should confirm these findings. Trial Registration: trialregister.nl Identifier: NL8871

Bihormonal Artificial Pancreas With Closed-Loop Glucose Control vs Current Diabetes Care After Total Pancreatectomy A Randomized Clinical Trial

Importance: Glucose control in patients after total pancreatectomy is problematic because of the complete absence of α- and β-cells, leading to impaired quality of life. A novel, bihormonal artificial pancreas (BIHAP), using both insulin and glucagon, may improve glucose control, but studies in this setting are lacking. Objective: To assess the efficacy and safety of the BIHAP in patients after total pancreatectomy. Design, Setting, and Participants: This randomized crossover clinical trial compared the fully closed-loop BIHAP with current diabetes care (ie, insulin pump or pen therapy) in 12 adult outpatients after total pancreatectomy. Patients were recruited between August 21 and November 16, 2020. This first-in-patient study began with a feasibility phase in 2 patients. Subsequently, 12 patients were randomly assigned to 7-day treatment with the BIHAP (preceded by a 5-day training period) followed by 7-day treatment with current diabetes care, or the same treatments in reverse order. Statistical analysis was by Wilcoxon signed rank and Mann-Whitney U tests, with significance set at a 2-sided P <.05. Main Outcomes and Measures: The primary outcome was the percentage of time spent in euglycemia (70-180 mg/dL [3.9-10 mmol/L]) as assessed by continuous glucose monitoring. Results: In total, 12 patients (7 men and 3 women; median [IQR] age, 62.5 [43.1-74.0] years) were randomly assigned, of whom 3 did not complete the BIHAP phase and 1 was replaced. The time spent in euglycemia was significantly higher during treatment with the BIHAP (median, 78.30%; IQR, 71.05%-82.61%) than current diabetes care (median, 57.38%; IQR, 52.38%-81.35%; P =.03). In addition, the time spent in hypoglycemia (<70 mg/dL [3.9 mmol/L]) was lower with the BIHAP (median, 0.00% [IQR, 0.00%-0.07%] vs 1.61% [IQR, 0.80%-3.81%]; P =.004). No serious adverse events occurred. Conclusions and Relevance: Patients using the BIHAP after total pancreatectomy experienced an increased percentage of time in euglycemia and a reduced percentage of time in hypoglycemia compared with current diabetes care, without apparent safety risks. Larger randomized trials, including longer periods of treatment and an assessment of quality of life, should confirm these findings. Trial Registration: trialregister.nl Identifier: NL8871