Association between preoperative evaluation with lung ultrasound and outcome in frail elderly patients undergoing orthopedic surgery for hip fractures: study protocol for an Italian multicenter observational prospective study (LUSHIP)
Authors: 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 ,   The LUSHIP Study Investigators, Mattuzzi Lisa , Federici Nicola , Delrio Silvia , Meroi Francesco , Flaibani Luca , Zaghis Clara , Orso Daniele , Tomasino Serena , Dottore Bruno , Divella Michele , Mussetta Sabrina , Musso Gaia , Minunno Angela , Barbero Carlo , Puppo Mattia , Saturno Francesco , Galvano Alberto Nicolò , Ippolito Mariachiara , Massari Leo , Bianconi Margherita , Caruso Gaetano , Ragazzi Riccardo , Volta Carlo Alberto , Mongodi Silvia , Mojoli Francesco , Riccone Filippo , Scolletta Sabino , Macheda Sebastiano , Vulcano Serafino , Cosco Giovanni , Vadalà Eugenio , Taddei Erika , Isirdi Alessandro 
Published: June 2021

Abstract
Background
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.

Methods
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.

Conclusions
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.