Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis
- Conditions
- DyspneaPatient Reported OutcomesDiaphragm MovementPleural EffusionUltrasound
- Interventions
- Other: Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesis
- Registration Number
- NCT04236934
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
- Age ≥ 18 years.
- Unilateral pleural effusion.
- A minimum of two thoracentesis prior to inclusion.
- Patients must be able to give informed consent.
- Bilateral pleural effusions.
- Inability to understand written or spoken Danish.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All included patients Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesis Patients with recurrent unilateral pleural effusion
- Primary Outcome Measures
Name Time Method 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
Name Time Method Fluid removed at the second study-thoracentesis At the day of the the second thoracentesis, immediately after end procedure measured in mL.
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 MRC (Medical Research Council Dyspnoea Scale, scale1-5, 1 being the least dyspnea, 5 being the worse dyspnea)
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.
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)
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)
Fluid removed at the first study-thoracentesis At day 1, immediately after end of procedure 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
Trial Locations
- Locations (2)
Zealand University Hospital, Roskilde
🇩🇰Roskilde, Zealand, Denmark
Næstved Sygehus, department of pulmonary medicine
🇩🇰Næstved, Region Sjælland, Denmark