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).


Journal

The ultrasound journal
ISSN: 2524-8987
Titre abrégé: Ultrasound J
Pays: Italy
ID NLM: 101742146

Informations de publication

Date de publication:
07 Jun 2021
Historique:
received: 12 03 2021
accepted: 25 05 2021
entrez: 8 6 2021
pubmed: 9 6 2021
medline: 9 6 2021
Statut: epublish

Résumé

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.

Sections du résumé

BACKGROUND 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 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 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.

Identifiants

pubmed: 34100124
doi: 10.1186/s13089-021-00230-w
pii: 10.1186/s13089-021-00230-w
pmc: PMC8184059
doi:

Banques de données

ClinicalTrials.gov
['NCT04074876']

Types de publication

Journal Article

Langues

eng

Pagination

30

Investigateurs

Lisa Mattuzzi (L)
Nicola Federici (N)
Silvia Delrio (S)
Francesco Meroi (F)
Luca Flaibani (L)
Clara Zaghis (C)
Daniele Orso (D)
Serena Tomasino (S)
Bruno Dottore (B)
Michele Divella (M)
Sabrina Mussetta (S)
Gaia Musso (G)
Angela Minunno (A)
Carlo Barbero (C)
Mattia Puppo (M)
Francesco Saturno (F)
Alberto Nicolò Galvano (AN)
Mariachiara Ippolito (M)
Leo Massari (L)
Margherita Bianconi (M)
Gaetano Caruso (G)
Riccardo Ragazzi (R)
Carlo Alberto Volta (CA)
Silvia Mongodi (S)
Francesco Mojoli (F)
Filippo Riccone (F)
Sabino Scolletta (S)
Sebastiano Macheda (S)
Serafino Vulcano (S)
Giovanni Cosco (G)
Eugenio Vadalà (E)
Erika Taddei (E)
Alessandro Isirdi (A)

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Auteurs

Luigi Vetrugno (L)

Department of Medicine, University of Udine, Via Colugna no. 50, 33100, Udine, Italy. luigi.vetrugno@uniud.it.
University-Hospital of Friuli Centrale, ASFC, P.le S. Maria della Misericordia no. 15, 33100, Udine, Italy. luigi.vetrugno@uniud.it.

Enrico Boero (E)

Anesthesia and Intensive Care Unit, San Giovanni Bosco Hospital, Turin, Italy.

Elena Bignami (E)

Anesthesiology, Critical Care and Pain Medicine Division, Department of Medicine and Surgery, University of Parma, Parma, Italy.

Andrea Cortegiani (A)

Department of Surgical, Oncological and Oral Science (Di.Chir.On.S), University of Palermo, Palermo, Italy.
Department of Anesthesia Intensive Care and Emergency, Policlinico Paolo Giaccone, Palermo, Italy.

Santi Maurizio Raineri (SM)

Department of Surgical, Oncological and Oral Science (Di.Chir.On.S), University of Palermo, Palermo, Italy.
Department of Anesthesia Intensive Care and Emergency, Policlinico Paolo Giaccone, Palermo, Italy.

Savino Spadaro (S)

Department of translational medicine, Anesthesia and Intensive Care, University of Ferrara, Ferrara, Italy.

Federico Moro (F)

Department of translational medicine, Anesthesia and Intensive Care, University of Ferrara, Ferrara, Italy.

Stefano D'Incà (S)

Department of Medicine, University of Udine, Via Colugna no. 50, 33100, Udine, Italy.

Loris D'Orlando (L)

Department of Medicine, University of Udine, Via Colugna no. 50, 33100, Udine, Italy.

Felice Eugenio Agrò (FE)

Department of Medicine, Unit of Anesthesia Intensive Care Pain Management, Università Campus Bio-Medico Di Roma, Rome, Italy.

Mattia Bernardinetti (M)

Department of Medicine, Unit of Anesthesia Intensive Care Pain Management, Università Campus Bio-Medico Di Roma, Rome, Italy.

Francesco Forfori (F)

Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.

Francesco Corradi (F)

Department of Anesthesia and Intensive Care, Ente Ospedaliero Ospedali Galliera, Genova, Italy.

Sandro Pregnolato (S)

Department of Clinical-Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.

Mario Mosconi (M)

Orthopedics and Traumatology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Valentina Bellini (V)

Anesthesiology, Critical Care and Pain Medicine Division, Department of Medicine and Surgery, University of Parma, Parma, Italy.

Federico Franchi (F)

Department of Medicine, Surgery and Neuroscience, Anesthesiology and Intensive Care, University of Siena, Siena, Italy.

Pierpaolo Mongelli (P)

Department of Medicine, Surgery and Neuroscience, Anesthesiology and Intensive Care, University of Siena, Siena, Italy.

Salvatore Leonardi (S)

IRCCS Centro Neurolesi Bonino-Pulejo, Messina, Italy.

Clemente Giuffrida (C)

IRCCS Centro Neurolesi Bonino-Pulejo, Messina, Italy.

Marco Tescione (M)

Anesthesia and Intensive Care Unit, Grande Ospedale Metropolitano, Reggio Calabria, Italy.

Andrea Bruni (A)

Anesthesia and Intensive Care Unit, Department of Medical and Surgical Science, Magna Graecia University, Catanzaro, Italy.

Eugenio Garofalo (E)

Anesthesia and Intensive Care Unit, Department of Medical and Surgical Science, Magna Graecia University, Catanzaro, Italy.

Federico Longhini (F)

Anesthesia and Intensive Care Unit, Department of Medical and Surgical Science, Magna Graecia University, Catanzaro, Italy.

Gianmaria Cammarota (G)

Section of Anaesthesia, Analgesia, and Intensive Care, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.

Edoardo De Robertis (E)

Section of Anaesthesia, Analgesia, and Intensive Care, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.

Giuseppe Giglio (G)

University-Hospital of Friuli Centrale, ASFC, P.le S. Maria della Misericordia no. 15, 33100, Udine, Italy.

Felice Urso (F)

Anesthesia and Intensive Care Unit, San Giovanni Bosco Hospital, Turin, Italy.

Tiziana Bove (T)

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.

Classifications MeSH