- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04236934
Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis
Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis: A Prospective Observational Study
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.
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Region Sjælland
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Næstved, Region Sjælland, Denmark, 4700
- Næstved Sygehus, department of pulmonary medicine
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Zealand
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Roskilde, Zealand, Denmark, 4000
- Zealand University Hospital, Roskilde
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
All included patients
Patients with recurrent unilateral pleural effusion
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Questionnaire is about symptoms measured by Edmonton Symptom Assessment Score (ESAS) and dyspnea also by modified Borg Scale (MBS)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Measured in days.
The patients and pulmonologists scheduling is recorded on a questionnaire at the day of first thoracentesis, after the procedure
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At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients experienced well being
Time Frame: At day 1 immediately prior to and immediately after thoracentesis
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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)
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At day 1 immediately prior to and immediately after thoracentesis
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Patients perception of dyspnea
Time Frame: At day 1 immediately prior to and immediately after thoracentesis.
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Symptoms measured by MBS (Modified Borg Scale, scale1-5, 1 being no dyspnea, 5 being the worse dyspnea)
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At day 1 immediately prior to and immediately after thoracentesis.
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Patients perception of dyspnea
Time Frame: At day 1 immediately prior to and immediately after thoracentesis.
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Symptoms measured by MRC (Medical Research Council Dyspnoea Scale, scale1-5, 1 being the least dyspnea, 5 being the worse dyspnea)
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At day 1 immediately prior to and immediately after thoracentesis.
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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.
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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)
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At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
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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.
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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)
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At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
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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.
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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)
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At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
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Fluid removed at the first study-thoracentesis
Time Frame: At day 1, immediately after end of procedure
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measured in mL.
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At day 1, immediately after end of procedure
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Fluid removed at the second study-thoracentesis
Time Frame: At the day of the the second thoracentesis, immediately after end procedure
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measured in mL.
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At the day of the the second thoracentesis, immediately after end procedure
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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.
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amount of fluid measured in mL.
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At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
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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.
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Time measured in days
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At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
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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.
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Time measured in days and amount of fluid measured in mL
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thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
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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
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Diaphragmatic movement (measured by M-mode and "The Area method", diaphragmatic shape (convex, flat, concave) and Septae-score)
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At day 1 immediately after ended procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Uffe Bødtger, MD, PhD, Department of Pulmonary Medicin, Næstved Sygehus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-000067
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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