1. 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.
- Author
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Posthuma LM, Breteler MJM, Lirk PB, Nieveen van Dijkum EJ, Visscher MJ, Breel JS, Wensing CAGL, Schenk J, Vlaskamp LB, van Rossum MC, Ruurda JP, Dijkgraaf MGW, Hollmann MW, Kalkman CJ, and Preckel B
- Abstract
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., Competing Interests: MB was part time employee of Luscii Healthech BV (Amsterdam, Netherlands) at the time of the study period. MH executive section editor for Pharmacology with Anesthesia & Analgesia and a section editor for Anesthesiologie with the Journal of Clinical Medicine. He has received honoraria for lectures and research support from Eurocept BV, BBraun, Edwards and Behring, and is an advisory board member for Eurocept BV. CK received funding from the European Commission for Precommercial Procurement project Nightingale (#727534, 2016-2021; development of wearable wireless monitoring). BP previously member of the Advisory Board of Sensium Healthcare, United Kingdom. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2024 Posthuma, Breteler, Lirk, Nieveen van Dijkum, Visscher, Breel, Wensing, Schenk, Vlaskamp, van Rossum, Ruurda, Dijkgraaf, Hollmann, Kalkman and Preckel.)
- Published
- 2024
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