Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis

NCT ID: NCT04236934

Last Updated: 2022-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-13

Study Completion Date

2022-04-04

Brief Summary

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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

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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.

Conditions

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Pleural Effusion Dyspnea Patient Reported Outcomes Diaphragm Movement Ultrasound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All included patients

Patients with recurrent unilateral pleural effusion

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

Intervention Type OTHER

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

Interventions

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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)

Intervention Type OTHER

Other Intervention Names

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A questionnaire before and after thoracentesis and daily until next therapeutic thoracentesis

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Naestved Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Uffe Bødtger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Pulmonary Medicin, Næstved Sygehus

Locations

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Næstved Sygehus, department of pulmonary medicine

Næstved, Region Sjælland, Denmark

Site Status

Zealand University Hospital, Roskilde

Roskilde, Region Sjælland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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19-000067

Identifier Type: -

Identifier Source: org_study_id

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