PrehospitaL Ultrasound in Undifferentiated DyspnEa (PreLUDE): a prospective, clinical, observational study.

BACKGROUND: Diagnostic uncertainty in patients with dyspnea is associated with worse outcomes. We hypothesized that prehospital point-of-care ultrasound (POCUS) can improve diagnostic accuracy.

METHODS: Prospective observational study of adult patients suffering dyspnea. Prehospital critical care physicians registered a suspected diagnosis based on clinical examination alone, performed POCUS of the heart and lungs, and finally registered suspected diagnoses based on their clinical examination supplemented with POCUS. Pre- and post-POCUS diagnoses were compared to endpoint committee adjudicated diagnoses. The primary outcome was improved sensitivity for diagnosing acute heart failure. Secondary outcomes included other diagnostic accuracy measures in relation to acute heart failure and other causes of dyspnea.

RESULTS: In total, 214 patients were included. The diagnosis of acute heart failure was suspected in 64/214 (30%) of patients before POCUS and 64/214 (30%) patients after POCUS, but POCUS led to reclassification in 53/214 (25%) patients. The endpoint committee adjudicated the diagnosis of acute heart failure in 87/214 (41%) patients. The sensitivity for the diagnosis of acute heart failure was 58% (95% CI 46%-69%) before POCUS compared to 65% (95% CI 53%-75%) after POCUS (p = 0.12). ROC AUC for the diagnosis acute heart failure was 0.72 (95% CI 0.66-0.78) before POCUS compared to 0.79 (0.73-0.84) after POCUS (p < 0.001). ROC AUC for the diagnosis acute exacerbation (AE) of chronic obstructive pulmonary disease (COPD) or asthma was 0.87 (0.82-0.91) before POCUS and 0.93 (0.88-0.97) after POCUS (p < 0.001). A POCUS finding of any of severely reduced left ventricular function, bilateral B-lines or bilateral pleural effusion demonstrated the highest sensitivity for acute heart failure at 88% (95% CI 79%-94%), whereas the combination of all of these three findings yielded the highest specificity at 99% (95% CI 95%-100%).

CONCLUSION: Supplementary prehospital POCUS leads to an improvement of diagnostic accuracy of both heart failure and AE-COPD/-asthma overall described by ROC AUC, but the increase in sensitivity for the diagnoses of acute heart failure did not reach statistical significance. Tailored use of POCUS findings optimizes diagnostic accuracy for rule-out and rule-in of acute heart failure.

TRIAL REGISTRATION: Registered in Clinical Trials, 05.04.2019 (identifier: NCT03905460) https://clinicaltrials.gov/ct2/show/study/NCT03905460?term=NCT03905460&cond=Dyspnea&cntry=DK&draw=2&rank=1 .