Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis
Study Details
Study Description
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 | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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 Names:
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Outcome Measures
Primary Outcome Measures
- Difference between time to next thoracentesis scheduled by the pulmonologist and patient respectively versus time to patient-reported need for thoracentesis [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
- Patients experienced well being [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)
- Patients perception of dyspnea [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)
- Patients perception of dyspnea [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)
- Patient experienced dyspnea until next thoracentesis [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)
- Patient experienced dyspnea until next thoracentesis [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)
- Patient experienced well being until next thoracentesis [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)
- Fluid removed at the first study-thoracentesis [At day 1, immediately after end of procedure]
measured in mL.
- Fluid removed at the second study-thoracentesis [At the day of the the second thoracentesis, immediately after end procedure]
measured in mL.
- 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. [At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.]
amount of fluid measured in mL.
- Correlation between patient's symptoms (well being and dyspnea, outcome 4, 5and 6) and time to next thoracentesis [At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.]
Time measured in days
- Correlation between time in between thoracentesis and amount of fluid drained at the following thoracentesis [thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.]
Time measured in days and amount of fluid measured in mL
- Correlation between well being and dyspnea (outcome 2, 3 and 4) and findings on lung ultrasound before and after completed thoracentesis [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years.
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Unilateral pleural effusion.
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A minimum of two thoracentesis prior to inclusion.
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Patients must be able to give informed consent.
Exclusion Criteria:
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Bilateral pleural effusions.
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Inability to understand written or spoken Danish.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Næstved Sygehus, department of pulmonary medicine | Næstved | Region Sjælland | Denmark | 4700 |
| 2 | Zealand University Hospital, Roskilde | Roskilde | Zealand | Denmark | 4000 |
Sponsors and Collaborators
- Naestved Hospital
Investigators
- Principal Investigator: Uffe Bødtger, MD, PhD, Department of Pulmonary Medicin, Næstved Sygehus
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-000067