Value of Additional Upfront Systematic Lung Ultrasound in the Workup of Patients With Unilateral Pleural Effusion

NCT ID: NCT04235998

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-17
• Study Completion Date: 2021-05-06

Brief Summary

The value of lung ultrasound in the work up of pleural effusion (fluid in between the thin doublet layered film surrounding the lungs) is unknown. The researchers will perform a systematic lung ultrasound scan including a scan for extra thoracic metastasis (spread of cancer to other organs) in the lymphnodes of the neck and metastasis lever in 56 patients one-sided pleural effusion. The researchers will measure if the interventions change the diagnostic plan for the patient and leads to faster diagnostics of the underlying course.

Conditions

Pleural Effusion; Malignant Pleural Effusion; Ultrasound

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Systematic lung ultrasound

Patients with unilateral pleural effusion of unknown course

Systematic lung ultrasound

Intervention Type: DIAGNOSTIC_TEST

Patients will undergo a systematic lung ultrasound including review of:

• Sonographic characteristic of effusion
• Parietal, diaphragmatic and visceral pleura
• Pleural nodules
• Lung parenchyma
• Extra pulmonary findings: Hepatic pathology, enlarged lymph nodes of the neck and a cardiac assessment.

Interventions

Systematic lung ultrasound

Patients will undergo a systematic lung ultrasound including review of:

• Sonographic characteristic of effusion
• Parietal, diaphragmatic and visceral pleura
• Pleural nodules
• Lung parenchyma
• Extra pulmonary findings: Hepatic pathology, enlarged lymph nodes of the neck and a cardiac assessment.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Unilateral pleural effusion of unknown course.
• Patients must be able to give informed consent.

Exclusion Criteria

• Bilateral pleural effusions.
• Known cause of pleural effusions.
• Life expectancy <3 months.
• Inability to understand written or spoken Danish.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Naestved Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uffe Bødtger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Pulmonary Medicin, Næstved Sygehus

Locations

Næstved Sygehus, department of pulmonary medicine

Næstved, Region Sjælland, Denmark

Countries

Denmark

Other Identifiers

SJ-789

Identifier Type: -

Identifier Source: org_study_id