Riishede M, Lassen A T, Baatrup G, Pietersen P I, Jacobsen N, Jeschke K N, Laursen C B
Department of Surgery, Odense University Hospital, 5700, Svendborg, Denmark.
Department of Clinical Research, University of Southern Denmark, SDU-Odense, 5000, Odense, Denmark.
Scand J Trauma Resusc Emerg Med. 2021 Apr 26;29(1):60. doi: 10.1186/s13049-021-00872-8.
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.
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.
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.
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.
https://clinicaltrials.gov/ , number NCT02550184 .
床旁超声是一种用于区分心肺疾病的聚焦式工具。其在不同超声经验的急诊医师手中的价值仍不确定。我们检验了这样一个假设：在有呼吸衰竭体征的急诊科患者中，与仅进行标准临床检查相比，由不同超声经验的急诊医师进行床旁心肺超声检查并结合标准临床检查，会使入院后4小时内初步诊断与最终诊断一致的患者比例增加。
在丹麦急诊科进行的这项前瞻性多中心优势试验中，我们通过区组随机化以1:1的比例将出现急性呼吸衰竭体征的患者随机分配至干预组或对照组。患者在入院后4小时内接受床旁心肺超声检查。干预组中负责治疗的急诊医师可了解超声检查结果。患者出院后，通过对病历进行盲法审查来确定最终诊断和治疗情况。
从2015年10月9日至2017年4月5日，我们随机分配了218例患者，最终纳入211例进行分析。在4小时时我们发现：初步诊断与最终诊断一致的患者比例没有变化；干预组为79.25%（95%置信区间70.3 - 86.0），对照组为77.1%（95%置信区间68.0 - 84.3），开具适当治疗的比例增加；干预组为79.3%（95%置信区间70.3 - 86.0），对照组为65.7%（95%置信区间56.0 - 74.3），住院时间少于1天的患者比例；干预组n = 42（39.6%，25.8 - 38.4），对照组n = 25（23.8%，16.5 - 33.0）。未报告不良事件。
对于有呼吸衰竭体征的患者，在标准临床检查基础上增加聚焦式心肺超声检查对诊断准确性没有影响，但显著增加了开具适当治疗方法的比例以及住院时间少于1天的患者比例。
https://clinicaltrials.gov/ ，编号NCT02550184 。
