Vetrugno Luigi, Boero Enrico, Bignami Elena, Cortegiani Andrea, Raineri Santi Maurizio, Spadaro Savino, Moro Federico, D'Incà Stefano, D'Orlando Loris, Agrò Felice Eugenio, Bernardinetti Mattia, Forfori Francesco, Corradi Francesco, Pregnolato Sandro, Mosconi Mario, Bellini Valentina, Franchi Federico, Mongelli Pierpaolo, Leonardi Salvatore, Giuffrida Clemente, Tescione Marco, Bruni Andrea, Garofalo Eugenio, Longhini Federico, Cammarota Gianmaria, De Robertis Edoardo, Giglio Giuseppe, Urso Felice, Bove Tiziana
Department of Medicine, University of Udine, Via Colugna no. 50, 33100, Udine, Italy.
University-Hospital of Friuli Centrale, ASFC, P.le S. Maria della Misericordia no. 15, 33100, Udine, Italy.
Ultrasound J. 2021 Jun 7;13(1):30. doi: 10.1186/s13089-021-00230-w.
Hip fracture is one of the most common orthopedic causes of hospital admission in frail elderly patients. Hip fracture fixation in this class of patients is considered a high-risk procedure. Preoperative physical examination, plasma natriuretic peptide levels (BNP, Pro-BNP), and cardiovascular scoring systems (ASA-PS, RCRI, NSQIP-MICA) have all been demonstrated to underestimate the risk of postoperative complications. We designed a prospective multicenter observational study to assess whether preoperative lung ultrasound examination can predict better postoperative events thanks to the additional information they provide in the form of "indirect" and "direct" cardiac and pulmonary lung ultrasound signs.
LUSHIP is an Italian multicenter prospective observational study. Patients will be recruited on a nation-wide scale in the 12 participating centers. Patients aged > 65 years undergoing spinal anesthesia for hip fracture fixation will be enrolled. A lung ultrasound score (LUS) will be generated based on the examination of six areas of each lung and ascribing to each area one of the four recognized aeration patterns-each of which is assigned a subscore of 0, 1, 2, or 3. Thus, the total score will have the potential to range from a minimum of 0 to a maximum of 36. The association between 30-day postoperative complications of cardiac and/or pulmonary origin and the overall mortality will be studied. Considering the fact that cardiac complications in patients undergoing hip surgery occur in approx. 30% of cases, to achieve 80% statistical power, we will need a sample size of 877 patients considering a relative risk of 1.5.
Lung ultrasound (LU), as a tool within the anesthesiologist's armamentarium, is becoming increasingly widespread, and its use in the preoperative setting is also starting to become more common. Should the study demonstrate the ability of LU to predict postoperative cardiac and pulmonary complications in hip fracture patients, a randomized clinical trial will be designed with the scope of improving patient outcome. Trial registration ClinicalTrials.gov, NCT04074876. Registered on August 30, 2019.
髋部骨折是体弱老年患者住院最常见的骨科病因之一。这类患者的髋部骨折固定术被认为是高风险手术。术前体格检查、血浆利钠肽水平（BNP、Pro-BNP）以及心血管评分系统（ASA-PS、RCRI、NSQIP-MICA）均已被证明低估了术后并发症的风险。我们设计了一项前瞻性多中心观察性研究，以评估术前肺部超声检查是否能借助其以“间接”和“直接”心脏及肺部超声征象形式提供的额外信息，更好地预测术后事件。
LUSHIP是一项意大利多中心前瞻性观察性研究。将在全国范围内的12个参与中心招募患者。将纳入年龄大于65岁、因髋部骨折固定术接受脊髓麻醉的患者。基于对每侧肺六个区域的检查并为每个区域赋予四种公认的通气模式之一（每种模式分别赋予0、1、2或3的子评分）来生成肺部超声评分（LUS）。因此，总分可能在0至36分之间。将研究术后30天心脏和/或肺部源性并发症与总体死亡率之间的关联。考虑到髋部手术患者心脏并发症发生率约为30%，为达到80%的统计效能，在相对风险为1.5的情况下，我们将需要877例患者的样本量。
肺部超声（LU）作为麻醉医生工具库中的一种工具，正日益普及，其在术前环境中的应用也开始变得更加常见。如果该研究证明LU能够预测髋部骨折患者术后心脏和肺部并发症，将设计一项随机临床试验以改善患者预后。试验注册ClinicalTrials.gov，NCT04074876。于2019年8月30日注册。
