Diagnosing Obstructive Lung Disease With Point of Care Ultrasound

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma; COPD
• Intervention / Treatment: Device: Point-of-Care Ultrasound

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 301

Contacts and Locations

Study Locations

• Israel
  • South
    • Beer Sheva, South, Israel, 8410101
      • Soroka University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Collaborators: Rabin Medical Center
• Investigators: Principal Investigator: Lior Fuchs, MD, Soroka University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. doi: 10.7326/L22-0020. Ann Intern Med. 2023 Apr;176(4):584. doi: 10.7326/L23-0043.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 27, 2024

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 27, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Dyspnea; Point-of-Care Ultrasound; Pulmonary Function Tests
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Protocol SOR-0185-23-CTIL; SCRC23032 (Other Identifier: Soroka Clinical Research Center); MOH_2023-10-04_012986 (Registry Identifier: Ministry of Health MyTrial)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No