NCT04264325: ADD-Echo

Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions : A Feasability Study

Completed Last updated 10 May 2023

What this trial tests

trial testing diaphragmatic ultrasound measure in Malignant Pleural Effusion in 15 participants. Completed in 3 May 2023.

Timeline

31 January 2020

Primary endpoint
20 August 2020

3 May 2023

Quick facts

Lead sponsor	University Hospital, Strasbourg, France
Status	Completed
Study type	OBSERVATIONAL
Enrollment	15
Start date	31 January 2020
Primary completion	20 August 2020
Estimated completion	3 May 2023
Sites	1 location across France

Drugs / interventions tested

• diaphragmatic ultrasound measure

Conditions studied

• Malignant Pleural Effusion — all drugs for Malignant Pleural Effusion →
• Lung Neoplasms — all drugs for Lung Neoplasms →

Sponsor

University Hospital, Strasbourg, France

Who can join

18 and older, any sex, with Malignant Pleural Effusion or Lung Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.