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Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis

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ClinicalTrials.gov Identifier: NCT04236934
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Naestved Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Pleural Effusion Dyspnea Patient Reported Outcomes Diaphragm Movement Ultrasound Other: Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesis

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 129 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis: A Prospective Observational Study
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : August 13, 2021
Estimated Study Completion Date : August 13, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
All included patients
Patients with recurrent unilateral pleural effusion
Other: Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesis
Questionnaire is about symptoms measured by Edmonton Symptom Assessment Score (ESAS) and dyspnea also by modified Borg Scale (MBS)
Other Name: A questionnaire before and after thoracentesis and daily until next therapeutic thoracentesis




Primary Outcome Measures :
  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 Outcome Measures :
  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. 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)

  4. 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)

  5. Fluid removed at the first study-thoracentesis [ Time Frame: At day 1, immediately after end of procedure ]
    measured in mL.

  6. Fluid removed at the second study-thoracentesis [ Time Frame: At the day of the the second thoracentesis, immediately after end procedure ]
    measured in mL.

  7. 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.

  8. Correlation between patient's symptoms (well being and dyspnea, outcome 4 and 5) 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

  9. 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

  10. Correlation between well being and dyspnea (outcome 2 and 3) 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referred to the Pleura Clinic (an outpatient clinic in the Department of Pulmonary Disease) at Næstved Sygehus or Zealand University Hospital, Roskilde (the two regional centers for work up of pulmonary malignancy). Patients are referred from the general practitioner or from other hospital departments both Næstved Sygehus and other hospitals.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236934


Contacts
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Contact: katrine fjællegaard, MD 20864959 kafj@regionsjaelland.dk

Locations
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Denmark
Næstved Sygehus, department of pulmonary medicine Recruiting
Næstved, Region Sjælland, Denmark, 4700
Contact: katrine fjællegaard, MD    20864959    kafj@regionsjaelland.dk   
Contact: Uffe Bødtger, MD, PhD         
Zealand University Hospital, Roskilde Not yet recruiting
Roskilde, Zealand, Denmark, 4000
Contact: katrine fjællegaard    20864959    kafj@regionsjaelland.dk   
Sponsors and Collaborators
Naestved Hospital
Investigators
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Principal Investigator: Uffe Bødtger, MD, PhD Department of Pulmonary Medicin, Næstved Sygehus

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Responsible Party: Naestved Hospital
ClinicalTrials.gov Identifier: NCT04236934    
Other Study ID Numbers: 19-000067
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyspnea
Pleural Effusion
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pleural Diseases