Clinical trial NCT06251271: Diagnosing Obstructive Lung Disease With Point of Care Ultrasound
Official title: Diagnosing Obstructive Lung Disease With Point of Care Ultrasound- A Cross-sectional, Diagnostic Accuracy Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Asthma
COPD
Keywords: Point-of-Care Ultrasound
Dyspnea
Pulmonary Function Tests
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: Rabin Medical Center
First posted: 2024-02-09
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Title: Comparative Accuracy of Point-of-Care Ultrasound and Pulmonary Function Tests in Respiratory Assessment
timeFrame: 12 Months
Secondary outcomes:
measure: Correlation Between Sonographic Score and CT Scan Results
timeFrame: 12 Months
measure: Sonographic Score Relationship with mMRC Dyspnea Scale
timeFrame: 12 Months
measure: Sonographic Score Correlation with Diffusion Lung Capacity (DLCO)
timeFrame: 12 Months
measure: Sonographic Predictors of Obstructive Lung Disease Diagnosis
timeFrame: 12 Months
measure: Impact of Smoking Status on Sonographic Scoring Accuracy for OLD
timeFrame: 12 Months
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
state: South
Study officials:
affiliation: Soroka University Medical Center
name: Lior Fuchs, MD
role: PRINCIPAL_INVESTIGATOR
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