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Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis

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ClinicalTrials.gov Identifier: NCT04236934
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Naestved Hospital

Tracking Information
First Submitted Date December 19, 2019
First Posted Date January 22, 2020
Last Update Posted Date January 22, 2020
Actual Study Start Date January 13, 2020
Estimated Primary Completion Date August 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 21, 2020)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 21, 2020)
  • 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)
  • 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)
  • 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)
  • 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)
  • Fluid removed at the first study-thoracentesis [ Time Frame: At day 1, immediately after end of procedure ]
    measured in mL.
  • Fluid removed at the second study-thoracentesis [ Time Frame: At the day of the the second thoracentesis, immediately after end procedure ]
    measured in mL.
  • 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.
  • Correlation between patient's symptoms (well being and dyspnea, outcome 4 and 5) 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
  • 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
  • Correlation between well being and dyspnea (outcome 2 and 3) 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Pleural Effusion
  • Dyspnea
  • Patient Reported Outcomes
  • Diaphragm Movement
  • 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)
Other Name: A questionnaire before and after thoracentesis and daily until next therapeutic thoracentesis
Study Groups/Cohorts All included patients
Patients with recurrent unilateral pleural effusion
Intervention: Other: Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 21, 2020)
129
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 13, 2021
Estimated Primary Completion Date August 13, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: katrine fjællegaard, MD 20864959 kafj@regionsjaelland.dk
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT04236934
Other Study ID Numbers 19-000067
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Naestved Hospital
Study Sponsor Naestved Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Uffe Bødtger, MD, PhD Department of Pulmonary Medicin, Næstved Sygehus
PRS Account Naestved Hospital
Verification Date January 2020