Diagnosing Obstructive Lung Disease With Point of Care Ultrasound- A Cross-sectional, Diagnostic Accuracy Test
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Soroka University Medical Center
- Enrollment
- 301
- Locations
- 1
- Primary Endpoint
- Title: Comparative Accuracy of Point-of-Care Ultrasound and Pulmonary Function Tests in Respiratory Assessment
- Status
- Completed
- Last Updated
- last year
Overview
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.
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.
Investigators
Lior Fuchs MD
MD
Soroka University Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Title: Comparative Accuracy of Point-of-Care Ultrasound and Pulmonary Function Tests in Respiratory Assessment
Time Frame: 12 Months
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.
Secondary Outcomes
- Sonographic Score Correlation with Diffusion Lung Capacity (DLCO)(12 Months)
- Correlation Between Sonographic Score and CT Scan Results(12 Months)
- Sonographic Score Relationship with mMRC Dyspnea Scale(12 Months)
- Sonographic Predictors of Obstructive Lung Disease Diagnosis(12 Months)
- Impact of Smoking Status on Sonographic Scoring Accuracy for OLD(12 Months)