Malignant Pleural EffusionADD-EchoNCT04264325
Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions : A Feasability Study
An observational study of Malignant Pleural Effusion and Lung Neoplasms, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Malignant pleural effusions cause breathlessness and impairs quality of life. Thoracocentesis is frequently used to relieve breathlessness. The severity of breathlessness correlates poorly with the size of the effusion. Symptom reduction from fluid drainage varies between patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusion, Lung Neoplasms
- What is being tested?
- diaphragmatic ultrasound measure
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2020to 3 May 2023
- 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: 30 patients with lung neoplasms and malignant pleural effusions who need a diagnostic or therapeutic thoracocentesis
Who may be able to join
- Age> 18 years old
- Male or female patient
- Patient with known lung cancer, regardless of histology or suspected of having unknown lung cancer or relapse / progression of lung cancer
- Presenting a pleural effusion with clinical necessity of evacuating pleural puncture
- Subject who expressed his non opposition to the research
Who cannot join
- Patient's refusal to participate in the study
- History of pleurodesis whatever the indication (pneumothorax or recurrent pleural effusion) or the technique used
- Permanent chest drain
- inability to provide informed information to the subject (subject in an emergency, difficulty understanding the subject, etc.)
- Subject under judicial protection
- Subject under guardianship or curatorship
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions
Malignant pleural effusions cause breathlessness and impairs quality of life. Thoracocentesis is frequently used to relieve breathlessness.
The severity of breathlessness correlates poorly with the size of the effusion. Symptom reduction from fluid drainage varies between patients. No predictors exist to identify which patients benefits more of pleural effusion. One study suggests that a inverted hemidiaphramatic (inverted shape) is associated with a greater dyspnea improvement. Others parameters of diaphragmatic motion have not been studied till now.
Read more
This study aims to evaluate the feasability of diaphragmatic ultrasound evaluation (shape by B-mode, quiet, deep inspiratory motion and sniff diaphragm motion by TM-mode) before and after pleural drainage.
Primary end point aims to evaluate the feasability of deep breath inspiratory excursion in ipsilateral side of thoracocentesis by anterior subcostal approach in the mid-clavicular line in the right in patients with malignant pleural effusions. The liver or spleen was identified as a window for each hemidiaphragm.
Secondary end points aim to evaluate
- the feasability of quiet breath inspiratory motion ,
- the feasability of sniff diaphragm motion
- the feasability of deep breath inspiratory motion by posterior method
- the comparaison of feasibility with different types of breathing and or anterior or posterior approach for ultrasound
- the feasability of the shape by B-mode.
- the correlation between the change of the shape of ipsilateral diaphragm and the evolution of dyspnea, before and after thoracocentesis.
- the correlation between the volume of pleural effusion evacuated and the evolution of dyspnea, before and after thoracocentesis.
- the comparaison of the changing of dyspnea in patients with noticed paradoxal movement of diaphragm before thoracocentesis and patients with persistent paradoxal/or non persistant paradoxal movement of ipsilateral hémidiaphragm.
- the correlation between the feasability of diaphragmatic ultrasound motion measurments evaluation and the body mass index.
- the comparaison between the different diaphragmatic ultrsound times for anterior or posterior approach.
- Conditions
- Malignant Pleural Effusion, Lung Neoplasms
- Being tested
- diaphragmatic ultrasound measure
- Keywords
- Dyspnea, Malignant pleural effusion, Lung Neoplasms, Therapeutic thoracocentesis, Lung ultrasound, Diaphragmatic ultrasound, Diaphragmatic dysfunction
- Medical subject headings
- Pleural Effusion, Malignant, Lung Neoplasms, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragmatic ultrasound measureOther
patients with lung neoplasms and malignant pleural effusions who need a diagnostic or therapeutic thoracocentesis
| Study group | Role | What they receive |
|---|---|---|
| Malignant pleural effusions : diaphragmatic ultrasound measure | Not described Receives: Other: diaphragmatic ultrasound measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the feasibility of measuring the diaphragmatic amplitude in wide breathing (RA) on the side homolateral to the pleural puncture
Rate of patients with a feasible measure of diaphragmatic amplitude in wide breathing (RA), on the side homolateral to the pleural puncture, by the anterior route before and after pleural puncture.
Measured: one day
Secondary outcomes (1)
Feasability of quiet breath inspiratory motion
Rate of patients with a feasible measure of diaphragmatic amplitude in spontaneous breathing (RS), on the side homolateral to the pleural puncture, by the anterior route before and after pleural puncture.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start31 Jan 2020
- Primary completion20 Aug 2020
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mickaël OHANA, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264325
- Sponsor's protocol ID
- 7565
- Acronym
- ADD-Echo
- Status last verified
- May 2023
- First submitted
- 30 Jan 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions
- ClinicalTrials.gov ID
- NCT04264325
- Acronym / sponsor ID
- ADD-Echo / 7565
- Conditions
- Malignant Pleural Effusion, Lung Neoplasms
- Keywords
- Dyspnea, Malignant pleural effusion, Lung Neoplasms, Therapeutic thoracocentesis, Lung ultrasound, Diaphragmatic ultrasound, Diaphragmatic dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 11 Feb 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.
Malignant pleural effusions cause breathlessness and impairs quality of life. Thoracocentesis is frequently used to relieve breathlessness.
The severity of breathlessness correlates poorly with the size of the effusion. Symptom reduction from fluid drainage varies between patients. No predictors exist to identify which patients benefits more of pleural effusion. One study suggests that a inverted hemidiaphramatic (inverted shape) is associated with a greater dyspnea improvement. Others parameters of diaphragmatic motion have not been studied till now.
This study aims to evaluate the feasability of diaphragmatic ultrasound evaluation (shape by B-mode, quiet, deep inspiratory motion and sniff diaphragm motion by TM-mode) before and after pleural drainage.
Primary end point aims to evaluate the feasability of deep breath inspiratory excursion in ipsilateral side of thoracocentesis by anterior subcostal approach in the mid-clavicular line in the right in patients with malignant pleural effusions. The liver or spleen was identified as a window for each hemidiaphragm.
Secondary end points aim to evaluate
- the feasability of quiet breath inspiratory motion ,
- the feasability of sniff diaphragm motion
- the feasability of deep breath inspiratory motion by posterior method
- the comparaison of feasibility with different types of breathing and or anterior or posterior approach for ultrasound
- the feasability of the shape by B-mode.
- the correlation between the change of the shape of ipsilateral diaphragm and the evolution of dyspnea, before and after thoracocentesis.
- the correlation between the volume of pleural effusion evacuated and the evolution of dyspnea, before and after thoracocentesis.
- the comparaison of the changing of dyspnea in patients with noticed paradoxal movement of diaphragm before thoracocentesis and patients with persistent paradoxal/or non persistant paradoxal movement of ipsilateral hémidiaphragm.
- the correlation between the feasability of diaphragmatic ultrasound motion measurments evaluation and the body mass index.
- the comparaison between the different diaphragmatic ultrsound times for anterior or posterior approach.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Malignant pleural effusions : diaphragmatic ultrasound measure | – | Other: diaphragmatic ultrasound measure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients with lung neoplasms and malignant pleural effusions who need a diagnostic or therapeutic thoracocentesis
Key inclusion criteria (5 listed)
- Age> 18 years old
- Male or female patient
- Patient with known lung cancer, regardless of histology or suspected of having unknown lung cancer or relapse / progression of lung cancer
- Presenting a pleural effusion with clinical necessity of evacuating pleural puncture
- Subject who expressed his non opposition to the research
Key exclusion criteria (7 listed)
- Patient's refusal to participate in the study
- History of pleurodesis whatever the indication (pneumothorax or recurrent pleural effusion) or the technique used
- Permanent chest drain
- inability to provide informed information to the subject (subject in an emergency, difficulty understanding the subject, etc.)
- Subject under judicial protection
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 |
|---|---|---|
| diaphragmatic ultrasound measurepatients with lung neoplasms and malignant pleural effusions who need a diagnostic or therapeutic thoracocentesis | Other | Malignant pleural effusions : diaphragmatic ultrasound measure |
Primary outcome
Evaluate the feasibility of measuring the diaphragmatic amplitude in wide breathing (RA) on the side homolateral to the pleural puncture
Time frame: one day
Rate of patients with a feasible measure of diaphragmatic amplitude in wide breathing (RA), on the side homolateral to the pleural puncture, by the anterior route before and after pleural puncture.
1 secondary outcome
Feasability of quiet breath inspiratory motion
Time frame: one day
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 10 May 2023.
- Individual participant dataSharing planned: Undecided
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RecruitingObservational study
UNC Pleural Fluid Registry
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Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
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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.
Mickaël OHANA principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Pleural Effusion and Lung Neoplasms, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 7 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Evaluate the feasibility of measuring the diaphragmatic amplitude in wide breathing (RA) on the side homolateral to the pleural puncture (time frame: one day). 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 10 May 2023.