Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis

Dyspnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04236934
• Other study ID #: 19-000067
• Status: Completed
• Start date: January 13, 2020
• Est. completion date: April 4, 2022

Study information

• Verified date: May 2022
• Source: Naestved Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: April 4, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diaphragm Movement
• Dyspnea
• Patient Reported Outcomes
• Pleural Effusion
• Ultrasound

Intervention

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)

Locations

Country	Name	City	State
Denmark	Næstved Sygehus, department of pulmonary medicine	Næstved	Region Sjælland
Denmark	Zealand University Hospital, Roskilde	Roskilde	Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Naestved Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Fluid removed at the first study-thoracentesis	measured in mL.	At day 1, immediately after end of procedure
Secondary	Fluid removed at the second study-thoracentesis	measured in mL.	At the day of the the second thoracentesis, immediately after end procedure
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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