Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions : A Feasability Study (ADD-Echo)
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|ClinicalTrials.gov Identifier: NCT04264325|
Recruitment Status : Not yet recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
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.
|Condition or disease||Intervention/treatment|
|Malignant Pleural Effusion Lung Neoplasms||Other: diaphragmatic ultrasound measure|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2021|
|Malignant pleural effusions : diaphragmatic ultrasound measure||
Other: diaphragmatic ultrasound measure
patients with lung neoplasms and malignant pleural effusions who need a diagnostic or therapeutic thoracocentesis
- 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.
- Feasability of quiet breath inspiratory motion [ Time Frame: one day ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264325
|Contact: Mickaël OHANA||+33 3 69 55 11 firstname.lastname@example.org|
|Les Hôpitaux Universitaires de Strasbourg|
|Strasbourg, France, 67091|
|Contact: Mickaël OHANA +33 3 69 55 11 17 email@example.com|
|Principal Investigator: Mickaël OHANA|
|Sub-Investigator: Elisabeth QUOIX|
|Principal Investigator:||Mickaël OHANA||Hôpitaux Universitaires de Strasbourg|