Point-of-care ultrasound of the heart and lungs in patients with respiratory failure: a pragmatic randomized controlled multicenter trial

M Riishede, A T Lassen, G Baatrup, P I Pietersen, N Jacobsen, K N Jeschke, C B Laursen, M Riishede, A T Lassen, G Baatrup, P I Pietersen, N Jacobsen, K N Jeschke, C B Laursen

Abstract

Background: Point-of-care ultrasound is a focus oriented tool for differentiating among cardiopulmonary diseases. Its value in the hands of emergency physicians, with various ultrasound experience, remains uncertain. We tested the hypothesis that, in emergency department patients with signs of respiratory failure, a point-of-care cardiopulmonary ultrasound along with standard clinical examination, performed by emergency physicians with various ultrasound experience would increase the proportion of patients with presumptive diagnoses in agreement with final diagnoses at four hours after admission compared to standard clinical examination alone.

Methods: In this prospective multicenter superiority trial in Danish emergency departments we randomly assigned patients presenting with acute signs of respiratory failure to intervention or control in a 1:1 ratio by block randomization. Patients received point-of-care cardiopulmonary ultrasound examination within four hours from admission. Ultrasound results were unblinded for the treating emergency physician in the intervention group. Final diagnoses and treatment were determined by blinded review of the medical record after the patients´ discharge.

Results: From October 9, 2015 to April 5, 2017, we randomized 218 patients and included 211 in the final analyses. At four hours we found; no change in the proportion of patients with presumptive diagnoses in agreement with final diagnoses; intervention 79·25% (95% CI 70·3-86·0), control 77·1% (95% CI 68·0-84·3), an increased proportion of appropriate treatment prescribed; intervention 79·3% (95% CI 70·3-86·0), control 65·7% (95% CI 56·0-74·3) and of patients who spent less than 1 day in hospital; intervention n = 42 (39·6%, 25·8 38·4), control n = 25 (23·8%, 16·5-33·0). No adverse events were reported.

Conclusions: Focused cardiopulmonary ultrasound added to standard clinical examination in patients with signs of respiratory failure had no impact on the diagnostic accuracy, but significantly increased the proportion of appropriate treatment prescribed and the proportion of patients who spent less than 1 day in hospital.

Trial registration: https://ichgcp.net/clinical-trials-registry/NCT02550184" title="See in ClinicalTrials.gov">NCT02550184 .

Keywords: Diagnostic accuracy; Emergency department; High acuity; Point–of-care ultrasound; Respiratory disease; Ultrasound.

Conflict of interest statement

M. Riishede is a member of the committee on ultrasound in the Danish Society for Emergency Medicine. M. Riishede has worked as an instructor on ultrasound courses for the Usabcd.org, the University of Aarhus and the University of Southern Denmark, Odense, Denmark. SECMA Medical Innovation, Denmark, lend ultrasound machine to M. Riishede and assisted with operator expertise for the introduction and instructions of the investigators.

N. Jacobsen: Dr. Jacobsen reports personal fees from The Region of Southern Denmark and Tryg Foundation for working as an instructor on a point-of-care lung ultrasound course for paramedics, outside the submitted work.

A.T. Lassen is funded by an unrestricted grant from the philantropic fund, Tryg Foundation, given to the University at Southern Denmark.

C.B. Laursen: Has received personal fee for giving lectures on an ultrasound course organized by GE Healthcare.

K.N. Jeschke, P.I. Pietersen and G. Baatrup have no conflicts of interests to declare.

Figures

Fig. 1
Fig. 1
Trial profile (appended). *The 7 randomized patients we lost due to loss of follow up are assessed to be missing at random and were excluded from all analyses as all outcomes were to be calculated by statistic approximation. They were lost as follows: 4 were caused by investigators in two hospitals who withdrew their consent to participation due to too busy working hours in the ED, in 2 the medical records were lost in the transition to a new electronic medical record system, and in 1 an unidentifiable personal ID number was written in the database. Abbreviations: ED (emergency department). PoCUS (Point-of-care ultrasound)

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