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| ID | Type | Description | Link |
|---|---|---|---|
| SCRC23032 | Other Identifier | Soroka Clinical Research Center | |
| MOH_2023-10-04_012986 | Registry Identifier | Ministry of Health MyTrial |
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| Name | Class |
|---|---|
| Rabin Medical Center | OTHER |
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The objective of this study is to evaluate the diagnostic accuracy of Point of Care Ultrasound (POCUS) in identifying obstructive lung diseases (OLDs), using pulmonary function tests (PFTs) as the gold standard for comparison.
In this cross-sectional diagnostic accuracy test, 200 patients meeting the inclusion criteria will be enrolled to undergo random POCUS scans at the respiratory institute of Soroka University Medical Center. These patients, referred for PFTs, will be provided with a sonographic score based on several criteria. The study aims to capture comprehensive data, including sonographic results and medical history, to assess the sensitivity, specificity, PPV, and NPV of POCUS in diagnosing OLDs. Data management and analysis will be the responsibility of the Soroka Clinical Research Center, ensuring rigorous oversight and reliable results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soroka University Medical Center Pulmonology Ward - 'All Comers' | In the Pulmonology Ward, the cohort will encompass 'All Comers'-any patient referred for PFTs who meets the inclusion criteria. This cross-sectional observational study will screen all eligible patients presenting at the ward, offering a comprehensive snapshot of the diagnostic accuracy of point-of-care ultrasound in this diverse patient population. |
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| Rabin Medical Center Pulmonology Ward - 'All Comers' | In the Pulmonology Ward, the cohort will encompass 'All Comers'-any patient referred for PFTs who meets the inclusion criteria. This cross-sectional observational study will screen all eligible patients presenting at the ward, offering a comprehensive snapshot of the diagnostic accuracy of point-of-care ultrasound in this diverse patient population. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-Care Ultrasound | Device | Patients will undergo routine point-of-care ultrasound scans as part of the diagnostic process. The collected sonographic data and PFT results will assess point-of-care ultrasound's accuracy in diagnosing OLDs within the natural clinical setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Title: Comparative Accuracy of Point-of-Care Ultrasound and Pulmonary Function Tests in Respiratory Assessment | This study aims to develop and validate a sonographic scoring system for Point-of-Care Ultrasound (POCUS) exams, using a scale from 0 to 10, where higher scores indicate worse respiratory function. The accuracy of POCUS in assessing respiratory function will be directly compared with outcomes from Pulmonary Function Tests (PFTs). Outcome measures will include the sensitivity, specificity, and overall accuracy of the sonographic scoring system in detecting respiratory abnormalities, alongside a comparison of diagnostic agreement between POCUS exams and PFT results. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Sonographic Score and CT Scan Results | This outcome will measure the correlation coefficient between the sonographic scoring system (scale of 0 to 10, with higher scores indicating worse outcomes) and CT scan results in detecting respiratory abnormalities. The aim is to quantify the strength and direction of the association between sonographic scores and objective findings on CT scans. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be screened at the respiratory institute of Soroka University Medical Center and will include patients who are referred for pulmonary function tests (PFTs) for any reason.
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| Name | Affiliation | Role |
|---|---|---|
| Lior Fuchs, MD | Soroka University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka University Medical Center | Beersheba | South | 8410101 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21345104 | Background | Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available. | |
| 31418060 | Background | Mayo PH, Copetti R, Feller-Kopman D, Mathis G, Maury E, Mongodi S, Mojoli F, Volpicelli G, Zanobetti M. Thoracic ultrasonography: a narrative review. Intensive Care Med. 2019 Sep;45(9):1200-1211. doi: 10.1007/s00134-019-05725-8. Epub 2019 Aug 15. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2023 | Feb 11, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008173 | Lung Diseases, Obstructive |
| D001249 | Asthma |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| 12 Months |
| Sonographic Score Relationship with mMRC Dyspnea Scale | This outcome will report the correlation between sonographic scores (on a scale of 0 to 10, where higher scores signify worse respiratory function) and the modified Medical Research Council (mMRC) dyspnea scale scores. The mMRC scale, ranging from 0 (no dyspnea) to 4 (severe dyspnea), assesses the severity of dyspnea. The analysis will measure how variations in sonographic scores align with patient-reported severity of dyspnea. | 12 Months |
| Sonographic Score Correlation with Diffusion Lung Capacity (DLCO) | The objective is to measure the correlation between sonographic scores (scale of 0 to 10, with higher scores indicating worse respiratory status) and diffusion lung capacity (DLCO) values. This outcome will report the strength of association between sonographic findings and DLCO measurements, providing insights into respiratory function. | 12 Months |
| Sonographic Predictors of Obstructive Lung Disease Diagnosis | This outcome will identify and quantify the predictive value of specific sonographic components for the diagnosis of Obstructive Lung Disease (OLD), utilizing a scoring system ranging from 0 to 10, where higher scores indicate worse respiratory status. The analysis will focus on the sensitivity and specificity of individual sonographic components, with OLD diagnosis as the outcome variable. | 12 Months |
| Impact of Smoking Status on Sonographic Scoring Accuracy for OLD | This analysis will measure the effect of smoking status on the diagnostic accuracy of the sonographic score for OLD, employing a scoring system from 0 to 10, where higher scores reflect worse respiratory health. Using regression analysis, the outcome will include estimates of the impact of smoking status on the probability of OLD diagnosis, adjusting for the sonographic score, and will quantify the additional diagnostic value provided by smoking status information. | 12 Months |
| 29550326 | Background | Johri AM, Durbin J, Newbigging J, Tanzola R, Chow R, De S, Tam J. Cardiac Point-of-Care Ultrasound: State-of-the-Art in Medical School Education. J Am Soc Echocardiogr. 2018 Jul;31(7):749-760. doi: 10.1016/j.echo.2018.01.014. Epub 2018 Mar 15. |
| 26844609 | Background | Sekiguchi H. Tools of the Trade: Point-of-Care Ultrasonography as a Stethoscope. Semin Respir Crit Care Med. 2016 Feb;37(1):68-87. doi: 10.1055/s-0035-1570353. Epub 2016 Feb 4. |
| 24060427 | Background | Alrajab S, Youssef AM, Akkus NI, Caldito G. Pleural ultrasonography versus chest radiography for the diagnosis of pneumothorax: review of the literature and meta-analysis. Crit Care. 2013 Sep 23;17(5):R208. doi: 10.1186/cc13016. |
| 23229753 | Background | Shah VP, Tunik MG, Tsung JW. Prospective evaluation of point-of-care ultrasonography for the diagnosis of pneumonia in children and young adults. JAMA Pediatr. 2013 Feb;167(2):119-25. doi: 10.1001/2013.jamapediatrics.107. |
| 24092475 | Background | Nazerian P, Vanni S, Volpicelli G, Gigli C, Zanobetti M, Bartolucci M, Ciavattone A, Lamorte A, Veltri A, Fabbri A, Grifoni S. Accuracy of point-of-care multiorgan ultrasonography for the diagnosis of pulmonary embolism. Chest. 2014 May;145(5):950-957. doi: 10.1378/chest.13-1087. |
| 34670045 | Background | Diaz-Gomez JL, Mayo PH, Koenig SJ. Point-of-Care Ultrasonography. N Engl J Med. 2021 Oct 21;385(17):1593-1602. doi: 10.1056/NEJMra1916062. No abstract available. |
| 33900792 | Background | Qaseem A, Etxeandia-Ikobaltzeta I, Mustafa RA, Kansagara D, Fitterman N, Wilt TJ; Clinical Guidelines Committee of the American College of Physicians; Batur P, Cooney TG, Crandall CJ, Hicks LA, Lin JS, Maroto M, Tice J, Tufte JE, Vijan S, Williams JW Jr. Appropriate Use of Point-of-Care Ultrasonography in Patients With Acute Dyspnea in Emergency Department or Inpatient Settings: A Clinical Guideline From the American College of Physicians. Ann Intern Med. 2021 Jul;174(7):985-993. doi: 10.7326/M20-7844. Epub 2021 Apr 27. |
| 28212836 | Background | Zanobetti M, Scorpiniti M, Gigli C, Nazerian P, Vanni S, Innocenti F, Stefanone VT, Savinelli C, Coppa A, Bigiarini S, Caldi F, Tassinari I, Conti A, Grifoni S, Pini R. Point-of-Care Ultrasonography for Evaluation of Acute Dyspnea in the ED. Chest. 2017 Jun;151(6):1295-1301. doi: 10.1016/j.chest.2017.02.003. Epub 2017 Feb 16. |
| 18403664 | Background | Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10. |
| 34209651 | Background | Szalontai K, Gemes N, Furak J, Varga T, Neuperger P, Balog JA, Puskas LG, Szebeni GJ. Chronic Obstructive Pulmonary Disease: Epidemiology, Biomarkers, and Paving the Way to Lung Cancer. J Clin Med. 2021 Jun 29;10(13):2889. doi: 10.3390/jcm10132889. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |