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

Pleural Effusion Clinical Trial

Official title:

Value of Additional Upfront Systematic Lung Ultrasound in the Workup of Patients With Unilateral Pleural Effusion: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235998
• Other study ID #: SJ-789
• Status: Completed
• Start date: February 17, 2020
• Est. completion date: May 6, 2021

Study information

• Verified date: May 2022
• Source: Naestved Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 6, 2021
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant
• Ultrasound

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Denmark	Næstved Sygehus, department of pulmonary medicine	Næstved	Region Sjælland

Sponsors (1)

Lead Sponsor	Collaborator
Naestved Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of cases where systematic lung ultrasound (LUS) change the planned diagnostic process for patients with unilateral pleural effusion.	Information found in electronic patient files. Comparison of diagnostics planned before systematic ultrasound and diagnostics planned after systematic ultrasound. Measured in proportion of included patients	26 weeks post procedure
Secondary	Characteristics of ultrasonic findings with additional systematic LUS.	Characteristics is recorded in the ultrasound protocol	Day 1, within 30 minutes after the end of procedure
Secondary	Proportion of cases where findings of clinical importance on systematic LUS were not identified at the initial contrast-enhanced CT thorax or PET-CT	CT thorax and PET-CT (as assessed by radiologist or clinician at the initial planning of diagnostic work-up)	Day 1 within 30 minutes after the end of procedure
Secondary	Proportion of cases where the change in the diagnostic process after LUS provide a diagnose	Information found in electronic patient files.	26 weeks post procedure
Secondary	The patient experienced pain during procedure score	Measured by a VAS (Visual Analogue Scale) scale 0-10, 0 being no pain, 10 being the worse pain	Day 1 within 30 minutes after the end of procedure
Secondary	Patient experienced time consumption	Measured by a 3-point Likert scale , scale1-3, 1 being not time consuming at all, 3 being very time consuming	Day 1 within 30 minutes after the end of procedure
Secondary	The patients willingness to have the same examination again in the future if necessary	Measured by a 5-point Likert scale, scale 1-5, 1 being definitely willing to have the examination again, 5 being definitely not willing to have the examination again	Day 1within 30 minutes after the end of procedure
Secondary	Mean extra time spend on systematic LUS compared to conventional US for guidance of thoracentesis	Measured in minutes.	Day 1 within 30 minutes after the end of procedure