Abstract
Early detection of abnormal vital signs is critical for timely management of acute hospitalised patients and continuous monitoring may improve this. We aimed to assess the association between preceding vital sign abnormalities and serious adverse events (SAE) in patients hospitalised with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Two hundred patients’ vital signs were wirelessly and continuously monitored with peripheral oxygen saturation, heart rate, and respiratory rate during the first 4 days after admission for AECOPD. Non-invasive blood pressure was also measured every 30–60 min. The primary outcome was occurrence of SAE according to international definitions within 30 days and physiological data were analysed for preceding vital sign abnormalities. Data were presented as the mean cumulative duration of vital sign abnormalities per 24 h and analysed using Wilcoxon rank sum test. SAE during ongoing continuous monitoring occurred in 50 patients (25%). Patients suffering SAE during the monitoring period had on average 455 min (SD 413) per 24 h of any preceding vital sign abnormality versus 292 min (SD 246) in patients without SAE, p = 0.08, mean difference 163 min [95% CI 61–265]. Mean duration of bradypnea (respiratory rate < 11 min−1) was 48 min (SD 173) compared with 30 min (SD 84) in patients without SAE, p = 0.01. In conclusion, the duration of physiological abnormalities was substantial in patients with AECOPD. There were no statistically significant differences between patients with and without SAE in the overall duration of preceding physiological abnormalities.
Study registration: http://ClinicalTrials.gov (NCT03660501). Date of registration: Sept 6 2018.
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Funding
The WARD-project receives core support from the Innovation Fund Denmark (8056-00055B); the Danish Cancer Society (R150-A9865-16-S48); Copenhagen Center for Health Technology (CACHET); Radiometer Medical Aps; Isansys Ltd; A.P. Møller Foundation and from Bispebjerg and Frederiksberg Hospital, Rigshospitalet and the Technical University of Denmark. No sponsor had any role in study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication.
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The guarantor of the study is CSM, EKA, and HBDS, from conception and design to conduct of the study, interpretation of results, and revision of the manuscript. ME was responsible for measurements, conducted data analyses and drafted the manuscript. SMR, KKG, CMP, JUJ, CHR, JM, and MS contributed to conception and design of the study and revised the manuscript. All the co-authors have provided important intellectual input and contributed considerably to the analyses and interpretation of the data. All the authors have approved the final version of the manuscript.
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CSM, EKA and HBDS have founded a start-up company, WARD247 ApS, with the aim of pursuing the regulatory and commercial activities of the WARD-project. WARD247 ApS has obtained license agreement for any WARD-project software and patents. One patent has been filed: “Wireless Assessment of Respiratory and circulatory Distress (WARD)–Clinical Support System (CSS)–an automated clinical support system to improve patient safety and outcomes”. None of the above entities has influence on the study design, conduct, analysis, or reporting. CSM also reports direct and indirect research funding from Merck, Sharp and Dohme Corp. and Boehringer Ingelheim outside the submitted work as well as lecture fees from Radiometer. EKA also reports institutional research funding from Norpharma A/S outside the submitted work as well as lecture fees from Radiometer. ME: received departmental funding from Merck, Sharp and Dohme Corp outside the submitted work.
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All the procedures performed were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Approval was granted by the Danish Ethics Committee for the Capital Region (H-18026653).
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Elvekjaer, M., Rasmussen, S.M., Grønbæk, K.K. et al. Clinical impact of vital sign abnormalities in patients admitted with acute exacerbation of chronic obstructive pulmonary disease: an observational study using continuous wireless monitoring. Intern Emerg Med 17, 1689–1698 (2022). https://doi.org/10.1007/s11739-022-02988-w
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DOI: https://doi.org/10.1007/s11739-022-02988-w