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

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ClinicalTrials.gov Identifier: NCT04074876
Recruitment Status : Not yet recruiting
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Tiziana Bove, University of Udine

Brief Summary:

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)

Condition or disease Intervention/treatment
Femur Fracture Device: Pulmonary echography

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Study Type : Observational
Estimated Enrollment : 877 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility of Pulmonary Echography for Evaluation of Patients Undergoing Orthopedic Surgery for Femur Fracture
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 one year ]
    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.


Secondary Outcome Measures :
  1. 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 challenge ]
    Estimate a correlation between echography and fluid challenge during surgery

  2. 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 one year ]
    Follow up for patients after orthopedic surgery and value consecutive pulmonary complications



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Publications:
Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof EL, Fleischmann KE, Freeman WK, Froehlich JB, Kasper EK, Kersten JR, Riegel B, Robb JF, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Buller CE, Creager MA, Ettinger SM, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW. ACC/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery) Developed in Collaboration With the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery. J Am Coll Cardiol. 2007 Oct 23;50(17):1707-32. Erratum in: J Am Coll Cardiol. 2008 Aug 26;52(9):794-7. Chaikof, Elliott [corrected to Chaikof, Elliott L].

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Responsible Party: Tiziana Bove, Professor, University of Udine
ClinicalTrials.gov Identifier: NCT04074876    
Other Study ID Numbers: Lung US orthopedic surgery
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tiziana Bove, University of Udine:
pulmonary ultrasound
urgency orthopedic surgery
major adverse cardiac events
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries