Femur FractureLUSHIPNCT04074876
Utility of Pulmonary Echography for Evaluation of Patients Undergoing Orthopedic Surgery for Femur Fracture
An observational study of Femur Fracture, run by University of Udine at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femur Fracture
- What is being tested?
- Pulmonary echography
- Type of treatment
- Medical device
- How many people
- 877 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2019to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Patients more of 65 years of age with femur fracture undergoing urgent surgery
- patients can undergo spinal anaesthesia
Who cannot join
- Absent consent, patients with acute heart failure or recent major cardiac events (< 6 months), known pulmonary parenchyma diseases (including pneumonia), general anaesthesia during surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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)
- Conditions
- Femur Fracture
- Being tested
- Pulmonary echography
- Keywords
- pulmonary ultrasound, urgency orthopedic surgery, major adverse cardiac events
- Medical subject headings
- Femoral Fractures, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary echographyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Pulmonary echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of ultrasound in predicting MACE (major adverse cardiovascular events) in the setting of the study
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.
Measured: pulmonary echography is made during pre-operative anesthesiologic evaluation, patients are in follow up for MACE for 30 days
Secondary outcomes (2)
Feasibility of echography in evaluation of the tolerance to fluid challenge during surgery
Estimate a correlation between echography and fluid challenge during surgery
Measured: pulmonary echography is made during pre-operative anesthesiologic evaluation, patients are evaluated during surgery for fluid tollerance
finding postoperative pulmonary complications
Follow up for patients after orthopedic surgery and value consecutive pulmonary complications
Measured: pulmonary echography is made during pre-operative anesthesiologic evaluation, patients are in follow up for postoperative pulmonary complications for 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 Dec 2019
- Primary completion21 Sep 2022
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 877 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiziana Bove, University of Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074876
- Sponsor's protocol ID
- Lung US orthopedic surgery
- Acronym
- LUSHIP
- Status last verified
- May 2024
- First submitted
- 12 Aug 2019
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hendrix JM, Garmon EH. American Society of Anesthesiologists Physical Status Classification System. 2025 Feb 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/
PubMed 28722969Lee TH, Marcantonio ER, Mangione CM, Thomas EJ, Polanczyk CA, Cook EF, Sugarbaker DJ, Donaldson MC, Poss R, Ho KK, Ludwig LE, Pedan A, Goldman L. Derivation and prospective validation of a simple index for prediction of cardiac risk of major noncardiac surgery. Circulation. 1999 Sep 7;100(10):1043-9. doi: 10.1161/01.cir.100.10.1043.
PubMed 10477528Fleisher 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. doi: 10.1016/j.jacc.2007.09.001. No abstract available.
PubMed 17950159Gupta PK, Gupta H, Sundaram A, Kaushik M, Fang X, Miller WJ, Esterbrooks DJ, Hunter CB, Pipinos II, Johanning JM, Lynch TG, Forse RA, Mohiuddin SM, Mooss AN. Development and validation of a risk calculator for prediction of cardiac risk after surgery. Circulation. 2011 Jul 26;124(4):381-7. doi: 10.1161/CIRCULATIONAHA.110.015701. Epub 2011 Jul 5.
PubMed 21730309De Hert S, Staender S, Fritsch G, Hinkelbein J, Afshari A, Bettelli G, Bock M, Chew MS, Coburn M, De Robertis E, Drinhaus H, Feldheiser A, Geldner G, Lahner D, Macas A, Neuhaus C, Rauch S, Santos-Ampuero MA, Solca M, Tanha N, Traskaite V, Wagner G, Wappler F. Pre-operative evaluation of adults undergoing elective noncardiac surgery: Updated guideline from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2018 Jun;35(6):407-465. doi: 10.1097/EJA.0000000000000817.
PubMed 29708905Vetrugno L, Langiano N, Gisonni R, Rizzardo A, Venchiarutti PE, Divella M, Pompei L, Causero A, Rocca GD. Prediction of early postoperative major cardiac events after elective orthopedic surgery: the role of B-type natriuretic peptide, the revised cardiac risk index, and ASA class. BMC Anesthesiol. 2014 Mar 21;14:20. doi: 10.1186/1471-2253-14-20.
PubMed 24655733O'Neill F, Carter E, Pink N, Smith I. Routine preoperative tests for elective surgery: summary of updated NICE guidance. BMJ. 2016 Jul 14;354:i3292. doi: 10.1136/bmj.i3292. No abstract available.
PubMed 27418436Knudsen CW, Omland T, Clopton P, Westheim A, Abraham WT, Storrow AB, McCord J, Nowak RM, Aumont MC, Duc P, Hollander JE, Wu AH, McCullough PA, Maisel AS. Diagnostic value of B-Type natriuretic peptide and chest radiographic findings in patients with acute dyspnea. Am J Med. 2004 Mar 15;116(6):363-8. doi: 10.1016/j.amjmed.2003.10.028.
PubMed 15006584Chakko S, Woska D, Martinez H, de Marchena E, Futterman L, Kessler KM, Myerberg RJ. Clinical, radiographic, and hemodynamic correlations in chronic congestive heart failure: conflicting results may lead to inappropriate care. Am J Med. 1991 Mar;90(3):353-9. doi: 10.1016/0002-9343(91)80016-f.
PubMed 1825901Lichtenstein DA. Lung ultrasound in the critically ill. Ann Intensive Care. 2014 Jan 9;4(1):1. doi: 10.1186/2110-5820-4-1.
PubMed 24401163Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.
PubMed 22392031Agricola E, Picano E, Oppizzi M, Pisani M, Meris A, Fragasso G, Margonato A. Assessment of stress-induced pulmonary interstitial edema by chest ultrasound during exercise echocardiography and its correlation with left ventricular function. J Am Soc Echocardiogr. 2006 Apr;19(4):457-63. doi: 10.1016/j.echo.2005.11.013.
PubMed 16581487Volpicelli G, Skurzak S, Boero E, Carpinteri G, Tengattini M, Stefanone V, Luberto L, Anile A, Cerutti E, Radeschi G, Frascisco MF. Lung ultrasound predicts well extravascular lung water but is of limited usefulness in the prediction of wedge pressure. Anesthesiology. 2014 Aug;121(2):320-7. doi: 10.1097/ALN.0000000000000300.
PubMed 24821071Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.
PubMed 20851923Kataoka H. Ultrasound pleural effusion sign as a useful marker for identifying heart failure worsening in established heart failure patients during follow-up. Congest Heart Fail. 2012 Sep-Oct;18(5):272-7. doi: 10.1111/j.1751-7133.2012.00285.x. Epub 2012 Mar 13.
PubMed 22994441
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Pulmonary Echography for Evaluation of Patients Undergoing Orthopedic Surgery for Femur Fracture
- ClinicalTrials.gov ID
- NCT04074876
- Acronym / sponsor ID
- LUSHIP / Lung US orthopedic surgery
- Conditions
- Femur Fracture
- Keywords
- pulmonary ultrasound, urgency orthopedic surgery, major adverse cardiac events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 877 participants (actual)
- Lead sponsor
- University of UdineUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with femur fracture | – | Device: Pulmonary echographyGroup 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) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients more of 65 years of age with femur fracture undergoing urgent surgery
- patients can undergo spinal anaesthesia
Key exclusion criteria (1 listed)
- Absent consent, patients with acute heart failure or recent major cardiac events (< 6 months), known pulmonary parenchyma diseases (including pneumonia), general anaesthesia during surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary echographyPulmonary 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 | Device | patients with femur fracture |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 28722969Hendrix JM, Garmon EH. American Society of Anesthesiologists Physical Status Classification System. 2025 Feb 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/
- Background: PubMed 10477528Lee TH, Marcantonio ER, Mangione CM, Thomas EJ, Polanczyk CA, Cook EF, Sugarbaker DJ, Donaldson MC, Poss R, Ho KK, Ludwig LE, Pedan A, Goldman L. Derivation and prospective validation of a simple index for prediction of cardiac risk of major noncardiac surgery. Circulation. 1999 Sep 7;100(10):1043-9. doi: 10.1161/01.cir.100.10.1043.
- Background: PubMed 17950159Fleisher 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. doi: 10.1016/j.jacc.2007.09.001. No abstract available.
- Background: PubMed 21730309Gupta PK, Gupta H, Sundaram A, Kaushik M, Fang X, Miller WJ, Esterbrooks DJ, Hunter CB, Pipinos II, Johanning JM, Lynch TG, Forse RA, Mohiuddin SM, Mooss AN. Development and validation of a risk calculator for prediction of cardiac risk after surgery. Circulation. 2011 Jul 26;124(4):381-7. doi: 10.1161/CIRCULATIONAHA.110.015701. Epub 2011 Jul 5.
- Background: PubMed 29708905De Hert S, Staender S, Fritsch G, Hinkelbein J, Afshari A, Bettelli G, Bock M, Chew MS, Coburn M, De Robertis E, Drinhaus H, Feldheiser A, Geldner G, Lahner D, Macas A, Neuhaus C, Rauch S, Santos-Ampuero MA, Solca M, Tanha N, Traskaite V, Wagner G, Wappler F. Pre-operative evaluation of adults undergoing elective noncardiac surgery: Updated guideline from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2018 Jun;35(6):407-465. doi: 10.1097/EJA.0000000000000817.
- Background: PubMed 24655733Vetrugno L, Langiano N, Gisonni R, Rizzardo A, Venchiarutti PE, Divella M, Pompei L, Causero A, Rocca GD. Prediction of early postoperative major cardiac events after elective orthopedic surgery: the role of B-type natriuretic peptide, the revised cardiac risk index, and ASA class. BMC Anesthesiol. 2014 Mar 21;14:20. doi: 10.1186/1471-2253-14-20.
- Background: PubMed 27418436O'Neill F, Carter E, Pink N, Smith I. Routine preoperative tests for elective surgery: summary of updated NICE guidance. BMJ. 2016 Jul 14;354:i3292. doi: 10.1136/bmj.i3292. No abstract available.
- Background: PubMed 15006584Knudsen CW, Omland T, Clopton P, Westheim A, Abraham WT, Storrow AB, McCord J, Nowak RM, Aumont MC, Duc P, Hollander JE, Wu AH, McCullough PA, Maisel AS. Diagnostic value of B-Type natriuretic peptide and chest radiographic findings in patients with acute dyspnea. Am J Med. 2004 Mar 15;116(6):363-8. doi: 10.1016/j.amjmed.2003.10.028.
- Background: PubMed 1825901Chakko S, Woska D, Martinez H, de Marchena E, Futterman L, Kessler KM, Myerberg RJ. Clinical, radiographic, and hemodynamic correlations in chronic congestive heart failure: conflicting results may lead to inappropriate care. Am J Med. 1991 Mar;90(3):353-9. doi: 10.1016/0002-9343(91)80016-f.
- Background: PubMed 24401163Lichtenstein DA. Lung ultrasound in the critically ill. Ann Intensive Care. 2014 Jan 9;4(1):1. doi: 10.1186/2110-5820-4-1.
- Background: PubMed 22392031Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.
- Background: PubMed 16581487Agricola E, Picano E, Oppizzi M, Pisani M, Meris A, Fragasso G, Margonato A. Assessment of stress-induced pulmonary interstitial edema by chest ultrasound during exercise echocardiography and its correlation with left ventricular function. J Am Soc Echocardiogr. 2006 Apr;19(4):457-63. doi: 10.1016/j.echo.2005.11.013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femur Fracture, run by University of Udine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04074876, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.