Diagnosing Obstructive Lung Disease With Point of Care Ultrasound

Asthma Clinical Trial

Official title:

Diagnosing Obstructive Lung Disease With Point of Care Ultrasound- A Cross-sectional, Diagnostic Accuracy Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06251271
• Other study ID #: Protocol SOR-0185-23-CTIL
• Secondary ID: SCRC23032MOH_202
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: Soroka University Medical Center
• Contact: Lior Fuchs, MD
• Phone: +972 53-522-1565
• Email: Liorfuchs[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or above

• Referral for full pulmonary function tests (PFTs)

• Patients are willing and able to sign a written informed consent form.

Exclusion Criteria:

• Unable to give written informed consent.

• Unable to remain supine.

• Poor effort at PFTs

• Subcutaneous emphysema

Related Conditions & MeSH terms

• Asthma
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Point-of-Care Ultrasound
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.

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer Sheva	South

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Chest. 2013 Aug;144(2):721. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Ann Intern Med. 2022 Mar;175(3):458-459. Ann Intern Med. 2023 Apr;176(4):584. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	12 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	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