M Riishede1,2,3,4, A T Lassen5,6, G Baatrup7,5, P I Pietersen5,8,9, N Jacobsen5,8,9, K N Jeschke10, C B Laursen5,8. 1. Department of Surgery, Odense University Hospital, 5700, Svendborg, Denmark. Minna.Riishede@rsyd.dk. 2. Department of Clinical Research, University of Southern Denmark, SDU-Odense, 5000, Odense, Denmark. Minna.Riishede@rsyd.dk. 3. Department of Internal Medicine & Emergency Medicine (M/FAM), Odense University Hospital, Valdemarsgade 53, 5700, Svendborg, Denmark. Minna.Riishede@rsyd.dk. 4. OPEN, Open Patient data Explorative Network, Odense University Hospital, 5000, Odense, Denmark. Minna.Riishede@rsyd.dk. 5. Department of Clinical Research, University of Southern Denmark, SDU-Odense, 5000, Odense, Denmark. 6. Department of Emergency Medicine, Odense University Hospital, 5000, Odense, Denmark. 7. Department of Surgery, Odense University Hospital, 5700, Svendborg, Denmark. 8. Department of Respiratory Medicine, Odense University Hospital, 5000, Odense, Denmark. 9. Regional Center for Technical Simulation (TechSim), Odense University Hospital, 5000, Odense, Denmark. 10. Department of Respiratory Medicine, Copenhagen University Hospital, 2650, Hvidovre, Denmark.
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://clinicaltrials.gov/ , number NCT02550184 .
RCT Entities:
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://clinicaltrials.gov/ , number NCT02550184 .
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