Diagnosing Obstructive Lung Disease With Point of Care Ultrasound

NCT06251271 | Completed

• 3 other identifiers: Protocol SOR-0185-23-CTILSCRC23032MOH_2023-10-04_012986
• Study Type: observational
• Target: 301
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Point-of-Care Ultrasound; Dyspnea; Pulmonary Function Tests

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Correlation Between Sonographic Score and CT Scan Results

  12 Months

• Sonographic Score Relationship with mMRC Dyspnea Scale

  12 Months

• Sonographic Score Correlation with Diffusion Lung Capacity (DLCO)

  12 Months

• Sonographic Predictors of Obstructive Lung Disease Diagnosis

  12 Months

• Impact of Smoking Status on Sonographic Scoring Accuracy for OLD

  12 Months

Study Arms (2)

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

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

Interventions

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.

Rabin Medical Center Pulmonology Ward - 'All Comers'; Soroka University Medical Center Pulmonology Ward - 'All Comers'

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18 or above
• Referral for full pulmonary function tests (PFTs)
• Patients are willing and able to sign a written informed consent form.

You may not qualify if:

• Unable to give written informed consent.
• Unable to remain supine.
• Poor effort at PFTs
• Subcutaneous emphysema

Sponsors & Collaborators

• Soroka University Medical Center: lead
• Rabin Medical Center: collaborator

Study Sites (1)

Soroka University Medical Center

Beersheba, South, 8410101, Israel

Location

Related Publications (12)

• 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.

  PMID: 21345104 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.

  PMID: 31418060 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.

  PMID: 29550326 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.

  PMID: 26844609 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.

  PMID: 24060427 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.

  PMID: 23229753 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.

  PMID: 24092475 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.

  PMID: 34670045 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.

  PMID: 33900792 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.

  PMID: 28212836 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.

  PMID: 18403664 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.

  PMID: 34209651 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Asthma; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Lior Fuchs, MD

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: August 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 27, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)