Diagnosing Obstructive Lung Disease With Point of Care Ultrasound

NCT ID: NCT06251271

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

301 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-07-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Asthma COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Point-of-Care Ultrasound

Intervention Type 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'

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.

Point-of-Care Ultrasound

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rabin Medical Center

OTHER

Sponsor Role collaborator

Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lior Fuchs MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lior Fuchs, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Soroka University Medical Center

Beersheba, South, Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21345104 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31418060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29550326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26844609 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24060427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23229753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24092475 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34670045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33900792 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28212836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18403664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34209651 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SCRC23032

Identifier Type: OTHER

Identifier Source: secondary_id

MOH_2023-10-04_012986

Identifier Type: REGISTRY

Identifier Source: secondary_id

Protocol SOR-0185-23-CTIL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.