Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis

May 10, 2022 updated by: Naestved Hospital

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

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

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Region Sjælland
      • Næstved, Region Sjælland, Denmark, 4700
        • Næstved Sygehus, department of pulmonary medicine
    • Zealand
      • Roskilde, Zealand, Denmark, 4000
        • Zealand University Hospital, Roskilde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients referred to the Pleura Clinic (an outpatient clinic in the Department of Pulmonary Disease) at Næstved Sygehus or Zealand University Hospital, Roskilde (the two regional centers for work up of pulmonary malignancy). Patients are referred from the general practitioner or from other hospital departments both Næstved Sygehus and other hospitals.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All included patients
Patients with recurrent unilateral pleural effusion
Questionnaire is about symptoms measured by Edmonton Symptom Assessment Score (ESAS) and dyspnea also by modified Borg Scale (MBS)
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
Time Frame: 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
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
Time Frame: 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)
At day 1 immediately prior to and immediately after thoracentesis
Patients perception of dyspnea
Time Frame: 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)
At day 1 immediately prior to and immediately after thoracentesis.
Patients perception of dyspnea
Time Frame: 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)
At day 1 immediately prior to and immediately after thoracentesis.
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.
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: At day 1, immediately after end of procedure
measured in mL.
At day 1, immediately after end of procedure
Fluid removed at the second study-thoracentesis
Time Frame: At the day of the the second thoracentesis, immediately after end procedure
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.
Time Frame: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
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 Frame: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
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 Frame: thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
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
Time Frame: 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)
At day 1 immediately after ended procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Uffe Bødtger, MD, PhD, Department of Pulmonary Medicin, Næstved Sygehus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

April 4, 2022

Study Registration Dates

First Submitted

December 19, 2019

First Submitted That Met QC Criteria

January 21, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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