Skip to main content
OpenTrials
Completed

NCT Number: NCT06251271

Diagnosing Obstructive Lung Disease With Point of Care Ultrasound

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Correlation Between Sonographic Score and CT Scan Results

    Time frame: 12 Months

    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.

  2. Sonographic Score Relationship with mMRC Dyspnea Scale

    Time frame: 12 Months

    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.

  3. Sonographic Score Correlation with Diffusion Lung Capacity (DLCO)

    Time frame: 12 Months

    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.

  4. Sonographic Predictors of Obstructive Lung Disease Diagnosis

    Time frame: 12 Months

    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.

  5. Impact of Smoking Status on Sonographic Scoring Accuracy for OLD

    Time frame: 12 Months

    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.

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Collaborators

  • Rabin Medical Center

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.