Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis

Study Overview
=================
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.

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

Conditions
-----------------
Pleural Effusion, Dyspnea, Patient Reported Outcomes, Diaphragm Movement, Ultrasound

Intervention / Treatment
-----------------
* Other: Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesis


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All included patients<br>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<br>* Questionnaire is about symptoms measured by Edmonton Symptom Assessment Score (ESAS) and dyspnea also by modified Borg Scale (MBS)<br>* Other names: A questionnaire before and after thoracentesis and daily until next therapeutic thoracentesis;|

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 | Measured in days. The patients and pulmonologists scheduling is recorded on a questionnaire at the day of first thoracentesis, after the procedure | At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients experienced well being | 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) | At day 1 immediately prior to and immediately after thoracentesis | 
| Patients perception of dyspnea | Symptoms measured by MBS (Modified Borg Scale, scale1-5, 1 being no dyspnea, 5 being the worse dyspnea) | At day 1 immediately prior to and immediately after thoracentesis. | 
| Patients perception of dyspnea | Symptoms measured by MRC (Medical Research Council Dyspnoea Scale, scale1-5, 1 being the least dyspnea, 5 being the worse dyspnea) | At day 1 immediately prior to and immediately after thoracentesis. | 
| Patient experienced dyspnea until next thoracentesis | 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) | At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first. | 
| Patient experienced dyspnea until next thoracentesis | 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) | At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first. | 
| Patient experienced well being until next thoracentesis | 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) | At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first. | 
| Fluid removed at the first study-thoracentesis | measured in mL. | At day 1, immediately after end of procedure | 
| Fluid removed at the second study-thoracentesis | measured in mL. | At the day of the the second thoracentesis, immediately after end procedure | 
| 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. | amount of fluid measured in mL. | At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first. | 
| Correlation between patient's symptoms (well being and dyspnea, outcome 4, 5and 6) and time to next thoracentesis | Time measured in days | At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first. | 
| Correlation between time in between thoracentesis and amount of fluid drained at the following thoracentesis | Time measured in days and amount of fluid measured in mL | thoracentesis or 2 months after the first study-thoracentesis, whichever comes first. | 
| Correlation between well being and dyspnea (outcome 2, 3 and 4) and findings on lung ultrasound before and after completed thoracentesis | Diaphragmatic movement (measured by M-mode and The Area method, diaphragmatic shape (convex, flat, concave) and Septae-score) | At day 1 immediately after ended procedure |