Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis

NCT04236934 | Completed DMC

• 1 other identifier: 19-000067
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Patients experienced well being

  At day 1 immediately prior to and immediately after thoracentesis

• Patients perception of dyspnea

  At day 1 immediately prior to and immediately after thoracentesis.

• Patients perception of dyspnea

  At day 1 immediately prior to and immediately after thoracentesis.

• Patient experienced dyspnea until next thoracentesis

  At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.

• Patient experienced dyspnea until next thoracentesis

  At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.

Study Arms (1)

All included patients

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

Interventions

Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesis OTHER

Questionnaire is about symptoms measured by Edmonton Symptom Assessment Score (ESAS) and dyspnea also by modified Borg Scale (MBS)

Also known as: A questionnaire before and after thoracentesis and daily until next therapeutic thoracentesis

All included patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years.
• Unilateral pleural effusion.
• Patients must be able to give informed consent.

You may not qualify if:

• Bilateral pleural effusions.
• Inability to understand written or spoken Danish.

Sponsors & Collaborators

• Naestved Hospital: lead

Study Sites (2)

Næstved Sygehus, department of pulmonary medicine

Næstved, Region Sjælland, 4700, Denmark

Location

Zealand University Hospital, Roskilde

Roskilde, Region Sjælland, 4000, Denmark

Location

MeSH Terms

Conditions

Pleural Effusion; Dyspnea

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Uffe Bødtger, MD, PhD

  Department of Pulmonary Medicin, Næstved Sygehus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 22, 2020
• Study Start: January 13, 2020
• Primary Completion: December 31, 2021
• Study Completion: April 4, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

DK (2)