Pleural EffusionNCT04236934
Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis
An observational study of Pleural Effusion and Dyspnea, run by Naestved Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Dyspnea, Patient Reported Outcomes
- What is being tested?
- Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesis
- How many people
- 107 participants
- Where
- 2 sitesDenmark
- Study dates
- 13 Jan 2020to 4 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years.
- Unilateral pleural effusion.
- A minimum of two thoracentesis prior to inclusion.
- Patients must be able to give informed consent.
Who cannot join
- Bilateral pleural effusions.
- Inability to understand written or spoken Danish.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Næstved Sygehus, department of pulmonary medicine
Næstved, Region Sjælland, 4700
Zealand University Hospital, Roskilde
Roskilde, Region Sjælland, 4000
About this study
Official title: 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.
Read the 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.
- Being tested
- Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesis
- Medical subject headings
- Pleural Effusion, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesisOther
Also called A questionnaire before and after thoracentesis and daily until next therapeutic thoracentesis
Questionnaire is about symptoms measured by Edmonton Symptom Assessment Score (ESAS) and dyspnea also by modified Borg Scale (MBS)
| Study group | Role | What they receive |
|---|---|---|
| All included patients | Patients with recurrent unilateral pleural effusion Receives: Other: Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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)
Measured: At day 1 immediately prior to and immediately after thoracentesis
Patients perception of dyspnea
Symptoms measured by MBS (Modified Borg Scale, scale1-5, 1 being no dyspnea, 5 being the worse dyspnea)
Measured: At day 1 immediately prior to and immediately after thoracentesis.
Patients perception of dyspnea
Symptoms measured by MRC (Medical Research Council Dyspnoea Scale, scale1-5, 1 being the least dyspnea, 5 being the worse dyspnea)
Measured: At day 1 immediately prior to and immediately after thoracentesis.
Patient experienced dyspnea until next thoracentesis
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)
Measured: At the day of the next thoracentesis or 2 months after the first study-thoracentesis, whichever comes first.
Patient experienced dyspnea until next thoracentesis
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)
Measured: 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
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)
Measured: 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
measured in mL.
Measured: At day 1, immediately after end of procedure
Fluid removed at the second study-thoracentesis
measured in mL.
Measured: 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.
amount of fluid measured in mL.
Measured: 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 measured in days
Measured: 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 measured in days and amount of fluid measured in mL
Measured: 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
Diaphragmatic movement (measured by M-mode and "The Area method", diaphragmatic shape (convex, flat, concave) and Septae-score)
Measured: At day 1 immediately after ended procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start13 Jan 2020
- Primary completion31 Dec 2021
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uffe Bødtger, MD, PhD, Principal investigator, Department of Pulmonary Medicin, Næstved Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236934
- Sponsor's protocol ID
- 19-000067
- Status last verified
- May 2022
- First submitted
- 19 Dec 2019
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04236934
- Acronym / sponsor ID
- 19-000067
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All included patients | – | Other: Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesisPatients with recurrent unilateral pleural effusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Unilateral pleural effusion.
- A minimum of two thoracentesis prior to inclusion.
- Patients must be able to give informed consent.
Key exclusion criteria (2 listed)
- Bilateral pleural effusions.
- Inability to understand written or spoken Danish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesisAlso: A questionnaire before and after thoracentesis and daily until next therapeutic thoracentesisQuestionnaire is about symptoms measured by Edmonton Symptom Assessment Score (ESAS) and dyspnea also by modified Borg Scale (MBS) | Other | All included patients |
Primary outcome
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
12 secondary outcomes
Patients experienced well being
Time frame: 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.
Patients perception of dyspnea
Time frame: 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.
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.
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.
Fluid removed at the first study-thoracentesis
Time frame: 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
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uffe Bødtger, MD, PhD principal investigator
Department of Pulmonary Medicin, Næstved Sygehus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion and Dyspnea, run by Naestved Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.