Clinical trial NCT04236934: Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis
Official title: Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleural Effusion
Dyspnea
Patient Reported Outcomes
Diaphragm Movement
Ultrasound
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Difference between time to next thoracentesis scheduled by the pulmonologist and patient respectively versus time to patient-reported need for thoracentesis
timeFrame: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
Secondary outcomes:
measure: Patients experienced well being
timeFrame: At day 1 immediately prior to and immediately after thoracentesis
measure: Patients perception of dyspnea
timeFrame: At day 1 immediately prior to and immediately after thoracentesis.
measure: Patients perception of dyspnea
timeFrame: At day 1 immediately prior to and immediately after thoracentesis.
measure: Patient experienced dyspnea until next thoracentesis
timeFrame: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
measure: Patient experienced dyspnea until next thoracentesis
timeFrame: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
measure: Patient experienced well being until next thoracentesis
timeFrame: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
measure: Fluid removed at the first study-thoracentesis
timeFrame: At day 1, immediately after end of procedure
measure: Fluid removed at the second study-thoracentesis
timeFrame: At the day of the the second thoracentesis, immediately after end procedure
measure: 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.
timeFrame: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
measure: Correlation between patient's symptoms (well being and dyspnea, outcome 4, 5and 6) and time to next thoracentesis
timeFrame: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
measure: Correlation between time in between thoracentesis and amount of fluid drained at the following thoracentesis
timeFrame: thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
measure: Correlation between well being and dyspnea (outcome 2, 3 and 4) and findings on lung ultrasound before and after completed thoracentesis
timeFrame: At day 1 immediately after ended procedure
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Næstved Sygehus, department of pulmonary medicine
state: Region Sjælland
city: Roskilde
country: Denmark
facility: Zealand University Hospital, Roskilde
state: Zealand
Study officials:
affiliation: Department of Pulmonary Medicin, Næstved Sygehus
name: Uffe Bødtger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: