Utility of Pulmonary Echography for Evaluation of Patients Undergoing Orthopedic Surgery for Femur Fracture (LUSHIP)

November 1, 2022 updated by: Tiziana Bove, University of Udine

The stratification of perioperative risk is an essential moment in the preoperative evaluation of the patient undergoing surgery especially in the setting of urgency. There is a very broad group of indexes used in the stratification of preoperative risk, like ASA-PS (American Society of Anesthesiologists Physical Status), RCRI (Revised Cardiac Risk Index) and NSQIP MICA (National Surgical Quality Improvement Program Myocardial Infarction or Cardiac Arrest). The role of some laboratory markers such as BNP has also been demonstrated. The fundamental point of all these scores is cardiocirculatory compensation.

There are concerns about the value of certain preoperative exams, especially in an urgent setting. Of them all, mostly chest X-ray is questioned. Chest X-ray, indeed, needs special costs, not always short execution times and the need for X-ray exposition. Furthermore, its utility is questionable in asymptomatic patients, in which there are often no alterations to be detected. Sensibility, for Thorax x-ray, is 41% for apical flow inversion, 27% for interstitial and 6% for alveolar oedema. In chronic decompensated patients, radiographic signs of congestion have a small diagnostic accuracy, being absent in 53% of patients with capillary pulmonary pressure between 16 and 29 mmHg and in 39% of those with wedge pressure more of 30 mmHg.

Pulmonary echography is a known method, that has different possible applications in diagnosis of the lung parenchymal and pleural disease.

Lung is made up for 80% of water. Extravascular lung water is physiologically less than 500 ml and it increases in the case of pathology. Augmentation of this water is detected reliably by echography.

B-lines are an echographic artefact that allows recognition of interstitial syndrome, having a sensibility of 93,4% and specificity of 93%. Presence of 3 or more of B-lines in 2 out of 4 fields of each hemithorax can identify a cardiac problem like pulmonary sub-oedema or chronic heart failure and it is known as Diffuse Interstitial Syndrome. Thorax X-ray, instead, detects these situations only when extravascular water exceeds 30%. That's why echography has been proposed as a method for evaluation of extravascular pulmonary water. Moreover, when lung air component is lost enough in subpleural area, it is possible to find little consolidations. A method of reporting different grades of loss of aeration of the lung (normal pattern, isolated B lines, coalescent B lines and consolidation) has been proposed as a tool for monitoring the aeration itself.

Pleural effusion is another sign that echography could detect. It is perfectly transonic and easy to see. Also, in this case, therefore, ultrasound is superior to X-ray, that has got sensibility, specificity and diagnostic accuracy of 67%, 70% and 67% respectively.

All this information could provide useful elements for preoperative patient management. Echography, indeed, is a bedside and real-time method, that can give rapid information about the cardiocirculatory situation of patients.

Using this method, that is non-invasive and easy, useful elements could be obtained, that could contribute to a better overview of clinical conditions of the patient in the preoperative setting.

In the particular field of urgency and, among all, in the setting of orthopaedic urgency for femur fracture, there is a need for a more rapid and comprehensive evaluation, giving that the patient has to be operated within 24-48 hours. This timing is often incompatible with a long and time-consuming evaluation of the patients. Furthermore, a complete cardiologic examination is beyond the requirements of international guidelines for intermediate surgery, since it doesn't change the perioperative management.

In this particular setting, hence, pulmonary echography could represent a more reliable and easier tool compared to thorax X-ray, often performed in non-optimal conditions (supine position, only anteroposterior chest X-ray).

In recent studies, percentage of major adverse cardiovascular events (atrial fibrillation, flutter, acute heart failure and non-fatal acute myocardial infarction) after hip fracture has settled around 24.8%. This data confirms the importance of a valid preoperative stratification in this setting.

From this perspective, this study aims to evaluate the utility of pulmonary echography as a preoperative method of investigation.

The principal aim is to evaluate the utility of the pulmonary echography in predicting the risk of patients undergoing urgent surgery for femur fracture.

Alternative objectives are:

  • Evaluate the predictability of LUS (lung ultrasound score) on the occurrence of MACE (major adverse cardiovascular events)
  • Verify feasibility of echographic evaluation in the estimation of fluid tolerance of patients undergoing orthopaedic surgery.
  • Evaluation of postoperative pulmonary complications (PPC)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

877

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Udine, Italy, 33100
        • S. Maria della Misericordia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted between the patients hospitalized in the Orthopaedic Ward of Udine's Hospital and other participating centres, because of femur fracture undergoing urgent surgery. Anesthesiology management will be in charge of the physicians of Anesthesiology Division of the same Hospital, according to the international guidelines concerning preoperative evaluation.

Description

Inclusion Criteria:

  • Patients more of 65 years of age with femur fracture undergoing urgent surgery
  • patients can undergo spinal anaesthesia

Exclusion Criteria:

  • Absent consent, patients with acute heart failure or recent major cardiac events (< 6 months), known pulmonary parenchyma diseases (including pneumonia), general anaesthesia during surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with femur fracture

Group is composed of patients more of 65 years of age with femur fracture undergoing urgent orthopedic surgery.

During normal pre-operative evaluation and classification based on principal scores and laboratory data, patients will be subjected to bedside pulmonary ultrasound.

Pulmonary ultrasound will evaluate the presence of one of four patterns (normal pattern, isolated B lines, coalescent B lines and consolidation) defined by Lung Ultrasound Score in the 6 fields for each hemithorax of the patient.

These patients will be later subjected to spinal anaesthesia and orthopedic surgery.

They will be follow for evaluation of MACE (major adverse cardiovascular events: atrial fibrillation, flutter, acute heart failure and non-fatal acute myocardial infarction)
Device: Pulmonary echography

Pulmonary echography during preoperative evaluation for patients undergoing urgency orthopedic surgery for femur fracture.

Pulmonary ultrasound will evaluate the presence of one of four patterns defined by Lung Ultrasound Score in the 6 fields for each hemithorax of the patient (2 anterior, 2 lateral and 2 posterior). Each region is defined by axillary lines (anterior and posterior) and then is divided into 2 subregions (superior and inferior), thus defining the 6 fields. For a comprehensive exam, all intercostal spaces in the setting of each field will have to be examined by sliding the probe along them . A score will be used for each field that will have this definition:

  • 0: normal pattern (A-lines)
  • 1: multiple B lines (at least 3 for field), well defined.
  • 2: B lines coalescent
  • 3: consolidation of any dimension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of ultrasound in predicting MACE (major adverse cardiovascular events) in the setting of the study
Time Frame: pulmonary echography is made during pre-operative anesthesiologic evaluation, patients are in follow up for MACE for 30 days
Patients are classified by echography pattern in four category (normal pattern (A-lines), well defined multiple B lines (at least 3 for field), B lines coalescent, consolidation of any dimension). After surgery, the occurrence of MACE during the whole follow-up period will be evaluate in the four category of patients.
pulmonary echography is made during pre-operative anesthesiologic evaluation, patients are in follow up for MACE for 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of echography in evaluation of the tolerance to fluid challenge during surgery
Time Frame: pulmonary echography is made during pre-operative anesthesiologic evaluation, patients are evaluated during surgery for fluid tollerance
Estimate a correlation between echography and fluid challenge during surgery
pulmonary echography is made during pre-operative anesthesiologic evaluation, patients are evaluated during surgery for fluid tollerance
finding postoperative pulmonary complications
Time Frame: pulmonary echography is made during pre-operative anesthesiologic evaluation, patients are in follow up for postoperative pulmonary complications for 30 days
Follow up for patients after orthopedic surgery and value consecutive pulmonary complications
pulmonary echography is made during pre-operative anesthesiologic evaluation, patients are in follow up for postoperative pulmonary complications for 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Udine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

September 26, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

August 29, 2019

First Posted (Actual)

August 30, 2019

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lung US orthopedic surgery

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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