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

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

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.

Study Overview

• Status: Completed
• Conditions: Pleural Effusion; Ultrasound; Malignant Pleural Effusion
• Intervention / Treatment: Diagnostic test: Systematic lung ultrasound

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• Denmark
  • Region Sjælland
    • Næstved, Region Sjælland, Denmark, 4700
      • Næstved Sygehus, department of pulmonary medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the Pleura Clinic (an outpatient clinic in the Department of Pulmonary Disease, Næstved Sygehus, on of two regional centers for work up of pulmonary malignancy ) from the general practitioner or from other hospital departments both Næstved Sygehus and other hospitals.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Systematic lung ultrasound; Patients with unilateral pleural effusion of unknown course	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Naestved Hospital
• Investigators: Principal Investigator: Uffe Bødtger, MD, PhD, Department of Pulmonary Medicin, Næstved Sygehus

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): May 6, 2021

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: January 19, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: SJ-789

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No