CompletedNot Applicable

Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions : A Feasability Study

France15 participantsStarted 2020-01-31

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate the feasibility of measuring the diaphragmatic amplitude in wide breathing (RA) on the side homolateral to the pleural puncture

Timeframe: one day

Trial details

NCT IDNCT04264325

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-08-20

View on ClinicalTrials.gov More Malignant Pleural Effusion trials