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NCT Number: NCT04235998

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

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.

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Key information

Conditions

Pleural Effusion Malignant Pleural Effusion Neoplasms Neoplasms by Site Pleural Diseases Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Ultrasound

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Næstved Sygehus, department of pulmonary medicine

Næstved, Region Sjælland, 4700, Denmark

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Systematic lung ultrasound

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.

Primary outcomes

  1. Proportion of cases where systematic lung ultrasound (LUS) change the planned diagnostic process for patients with unilateral pleural effusion.

    Time frame: 26 weeks post procedure

    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

Secondary outcomes

  1. Characteristics of ultrasonic findings with additional systematic LUS.

    Time frame: Day 1, within 30 minutes after the end of procedure

    Characteristics is recorded in the ultrasound protocol

  2. Proportion of cases where findings of clinical importance on systematic LUS were not identified at the initial contrast-enhanced CT thorax or PET-CT

    Time frame: Day 1 within 30 minutes after the end of procedure

    CT thorax and PET-CT (as assessed by radiologist or clinician at the initial planning of diagnostic work-up)

  3. Proportion of cases where the change in the diagnostic process after LUS provide a diagnose

    Time frame: 26 weeks post procedure

    Information found in electronic patient files.

  4. The patient experienced pain during procedure score

    Time frame: Day 1 within 30 minutes after the end of procedure

    Measured by a VAS (Visual Analogue Scale) scale 0-10, 0 being no pain, 10 being the worse pain

  5. Patient experienced time consumption

    Time frame: Day 1 within 30 minutes after the end of procedure

    Measured by a 3-point Likert scale , scale1-3, 1 being not time consuming at all, 3 being very time consuming

  6. The patients willingness to have the same examination again in the future if necessary

    Time frame: Day 1within 30 minutes after the end of procedure

    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

  7. Mean extra time spend on systematic LUS compared to conventional US for guidance of thoracentesis

    Time frame: Day 1 within 30 minutes after the end of procedure

    Measured in minutes.

Sponsors and collaborators

Lead sponsor

Naestved Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jan 22, 2020
Registry last updated
May 11, 2022

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.

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