Abstract
Purpose
Point-of-care ultrasonography (POCUS) is an established tool in the management of hypotensive patients in the emergency department (ED). We compared the diagnostic accuracy of a POCUS protocol versus standard assessment without POCUS in patients with undifferentiated hypotension.
Methods
This was an international, multicenter randomized controlled trial included three EDs in North America and three in South Africa from September 2012 to December 2016. Hypotensive patients were randomized to early POCUS protocol plus standard care (POCUS group) or standard care without POCUS (control group). Initial and secondary diagnoses were recorded at 0 and 60 min. The main outcome was measures of diagnostic accuracy of a POCUS protocol in differentiating between cardiogenic and non-cardiogenic shock. Secondary outcomes were diagnostic performance for shock sub-types, as well as changes in perceived category of shock and overall diagnosis.
Results
Follow-up was completed for 270 of 273 patients. For cardiogenic shock, the POCUS-based diagnostic approach (POCUS) performed similarly to the non-POCUS approach (control) for specificity [95.5% (89.9–98.5) vs.93.8% (87.7–97.5)]; positive likelihood ratio (17.92 vs 14.80); negative likelihood ratio (0.21 vs 0.09) and diagnostic odds ratio (85.6 vs 166.57), with a similar overall diagnostic accuracy between the two approaches [93.7% (88–97.2) vs 93.6% (87.8–97.2)]. Diagnostic performance measures were similar across sub-categories of shock.
Conclusion
This is the first randomized controlled trial to compare diagnostic performance of a POCUS protocol to standard care without POCUS in undifferentiated hypotensive ED patients. POCUS performed well diagnostically in undifferentiated hypotensive patients, especially as a rule-in test; however, performance did not differ meaningfully from standard assessment.
Résumé
Objectif
L'échographie au point d'intervention (POCUS) est un outil bien établi dans la gestion des patients hypotendus dans le service des urgences. Nous avons comparé la précision diagnostique d'un protocole POCUS par rapport à une évaluation standard sans POCUS chez des patients présentant une hypotension indifférenciée.
Méthodes
Il s'agissait d'un essai contrôlé randomisé international multicentrique incluant 3 services d'urgence en Amérique du Nord et 3 en Afrique du Sud de septembre 2012 à décembre 2016. Les patients hypotenseurs ont été répartis par randomisation selon le protocole POCUS précoce plus les soins standard (groupe POCUS) ou les soins standard sans POCUS (groupe témoin). Les diagnostics initiaux et secondaires ont été enregistrés à 0 et 60 minutes. Le principal résultat était la mesure de la précision diagnostique d'un protocole POCUS pour différencier le choc cardiogénique du choc non cardiogénique. Les résultats secondaires étaient la performance diagnostique pour les sous-types de chocs, ainsi que les changements dans la perception de la catégorie de choc et du diagnostic global.
Résultats
Le suivi a été complété pour 270 des 273 patients. Pour le choc cardiogénique, l'approche diagnostique basée sur le POCUS (POCUS) a donné des résultats similaires à l'approche non-POCUS (Contrôle) pour la spécificité (95,5 % (89,9–98,5) vs 93,8 % (87,7–97,5)) ; Rapport de vraisemblance positif (17,92 vs 14,80) ; Le rapport de vraisemblance négatif (0,21 vs 0,09) et le rapport de cotes diagnostiques (85,6 vs 166,57), avec une précision diagnostique globale similaire entre les deux approches (93,7 % (88–97,2) vs 93,6 % (87,8–97,2). Les mesures de performance diagnostique étaient similaires dans toutes les sous-catégories de choc.
Conclusion
Il s'agit du premier essai contrôlé randomisé visant à comparer la performance diagnostique d'un protocole POCUS aux soins standard sans POCUS chez des patients hypotendus indifférenciés aux urgences. La POCUS a donné de bons résultats diagnostiques chez les patients hypotendus indifférenciés, surtout en tant que test de référence ; cependant, les performances ne diffèrent pas de manière significative de l'évaluation standard.
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Data availability
The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.
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Acknowledgements
The authors wish to thank the clinical staff at all participating sites for their help in identifying patients for this study and for their participation in performing the required ultrasound examinations and clinical assessments, as well as for the advice and monitoring provided by Horizon Health Network Research Ethics Board. We also wish to thank Prof. Jerome Hoffman, as well as members of the International Federation for Emergency Medicine (IFEM) Ultrasound Interest Group for their advice and review of the study. The study was supported by grants from the Horizon Health Network Health Promotion and Research Fund and the Chesley Foundation (New Brunswick, Canada). There was no industry sponsorship.
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The study was designed by PA, JM, JF and HL. This analysis was led by MP. All authors participated in data collection and analysis, and contributed to the final manuscript. The authors have no conflicts of interest to declare.
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Peach, M., Milne, J., Diegelmann, L. et al. Does point-of-care ultrasonography improve diagnostic accuracy in emergency department patients with undifferentiated hypotension? An international randomized controlled trial from the SHOC-ED investigators. Can J Emerg Med 25, 48–56 (2023). https://doi.org/10.1007/s43678-022-00431-9
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DOI: https://doi.org/10.1007/s43678-022-00431-9