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Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions : A Feasability Study

NCT04264325 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2023-05-10

No results posted yet for this study

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.

Conditions

  • Malignant Pleural Effusion
  • Lung Neoplasms

Interventions

OTHER

diaphragmatic ultrasound measure

patients with lung neoplasms and malignant pleural effusions who need a diagnostic or therapeutic thoracocentesis

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Mickaël OHANA · Hôpitaux Universitaires de Strasbourg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2020-08-20
Completion
2023-05-03

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04264325 on ClinicalTrials.gov