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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief 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.

Condition or disease Intervention/treatment
Malignant Pleural Effusion Lung Neoplasms Other: diaphragmatic ultrasound measure

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30 patients with lung neoplasms and malignant pleural effusions who need a diagnostic or therapeutic thoracocentesis
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Mickaël OHANA +33 3 69 55 11 17 mickael.ohana@chru-strasbourg.fr

Locations
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France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Contact: Mickaël OHANA    +33 3 69 55 11 17    mickael.ohana@chru-strasbourg.fr   
Principal Investigator: Mickaël OHANA         
Sub-Investigator: Elisabeth QUOIX         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Mickaël OHANA Hôpitaux Universitaires de Strasbourg
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04264325    
Other Study ID Numbers: 7565
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Dyspnea
Malignant pleural effusion
Lung Neoplasms
Therapeutic thoracocentesis
Lung ultrasound
Diaphragmatic ultrasound
Diaphragmatic dysfunction
Additional relevant MeSH terms:
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Lung Neoplasms
Pleural Effusion, Malignant
Pleural Effusion
Neoplasms
Pleural Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Pleural Neoplasms