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NCT Number: NCT04236934

Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis

Recurrent fluid surrounding the lungs is associated with poor quality of life, the main symptom being dyspnea. These patients are in need of recurrent removal of the fluid using drainage. The mechanism causing dyspnea is not fully understood.

By using ultrasound to evaluate the movement of the diaphragm before and after removal of fluid and the patients symptoms before removal of fluid and until next removal the research group aims to clarify the temporal development in symptoms and the role of the diaphragm.

The researchers will also evaluate the ability of the pulmonologist and patient to predict when the patient will need the next removal of fluid in patients with recurrent unilateral pleural effusion.

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Key information

Conditions

Pleural Effusion Diaphragm Movement Dyspnea Pathological Conditions, Signs and Symptoms Patient Reported Outcomes Pleural Diseases Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory 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, Denmark

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About this study

Recurrent pleural effusion (PE) is associated with impaired quality of life, the main symptom being dyspnea. The mechanisms causing dyspnea in PE is not fully understood. These patients are in need of recurrent therapeutic thoracentesis.

By evaluating the movement of diaphragma before and after thoracentesis and measure the patients symptoms before thoracentesis and until the next thoracentesis the researchers aim to clarify the temporal development in symptoms and the role of the diaphragm.

The researchers will also evaluate the ability of the pulmonologist and patient to predict when the patient will need the next therapeutic thoracentesis in patients with recurrent unilateral pleural effusion.

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.
  • A minimum of two thoracentesis prior to inclusion.
  • Patients must be able to give informed consent.

Exclusion criteria

  • Bilateral pleural effusions.
  • Inability to understand written or spoken Danish.

Treatment and study plan

Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesis

Other

Questionnaire is about symptoms measured by Edmonton Symptom Assessment Score (ESAS) and dyspnea also by modified Borg Scale (MBS)

Other names: A questionnaire before and after thoracentesis and daily until next therapeutic thoracentesis

Primary outcomes

  1. Difference between time to next thoracentesis scheduled by the pulmonologist and patient respectively versus time to patient-reported need for thoracentesis

    Time frame: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.

    Measured in days. The patients and pulmonologists scheduling is recorded on a questionnaire at the day of first thoracentesis, after the procedure

Secondary outcomes

  1. Patients experienced well being

    Time frame: At day 1 immediately prior to and immediately after thoracentesis

    Symptoms measured by ESAS (Edmonton Symptom Assessment System, contains visual analogue scales measuring tiredness, pain, drowsiness, nausea, appetite, dyspnea, depression, anxiety, and general well being, scale 0-10, 0 being no symptoms, 10 being the worse symptoms)

  2. Patients perception of dyspnea

    Time frame: At day 1 immediately prior to and immediately after thoracentesis.

    Symptoms measured by MBS (Modified Borg Scale, scale1-5, 1 being no dyspnea, 5 being the worse dyspnea)

  3. Patients perception of dyspnea

    Time frame: At day 1 immediately prior to and immediately after thoracentesis.

    Symptoms measured by MRC (Medical Research Council Dyspnoea Scale, scale1-5, 1 being the least dyspnea, 5 being the worse dyspnea)

  4. Patient experienced dyspnea until next thoracentesis

    Time frame: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.

    Measured in a daily diary completed at the same time slot every day by MBS (Modified Borg Scale, scale1-5, 1 being no dyspnea, 5 being the worse dyspnea)

  5. Patient experienced dyspnea until next thoracentesis

    Time frame: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.

    Measured in a daily diary completed at the same time slot every day by Measured in a daily diary completed at the same time slot every day by MRC (Medical Research Council Dyspnoea Scale, scale1-5, 1 being the least dyspnea, 5 being the worse dyspnea)

  6. Patient experienced well being until next thoracentesis

    Time frame: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.

    Measured in a daily diary completed at the same time slot every day by ESAS Symptoms measured by ESAS (Edmonton Symptom Assessment System, contains visual analogue scales measuring tiredness, pain, drowsiness, nausea, appetite, dyspnea, depression, anxiety, and general well being, scale 0-10, 0 being no symptoms, 10 being the worse symptoms)

  7. Fluid removed at the first study-thoracentesis

    Time frame: At day 1, immediately after end of procedure

    measured in mL.

  8. Fluid removed at the second study-thoracentesis

    Time frame: At the day of the the second thoracentesis, immediately after end procedure

    measured in mL.

  9. Correlation between amount of pleural fluid removed at the first study-thoracentesis (outcome 6) and symptoms (well being and dyspnea, outcome 4 and 5) until next thoracentesis.

    Time frame: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.

    amount of fluid measured in mL.

  10. Correlation between patient's symptoms (well being and dyspnea, outcome 4, 5and 6) and time to next thoracentesis

    Time frame: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.

    Time measured in days

  11. Correlation between time in between thoracentesis and amount of fluid drained at the following thoracentesis

    Time frame: thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.

    Time measured in days and amount of fluid measured in mL

  12. Correlation between well being and dyspnea (outcome 2, 3 and 4) and findings on lung ultrasound before and after completed thoracentesis

    Time frame: At day 1 immediately after ended procedure

    Diaphragmatic movement (measured by M-mode and "The Area method", diaphragmatic shape (convex, flat, concave) and Septae-score)

Sponsors and collaborators

Lead sponsor

Naestved Hospital

Other

Registry information

Official study title

Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis: A Prospective Observational Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
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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