Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions : A Feasability Study

Lung Neoplasms Clinical Trial

— ADD-Echo  

Official title:

Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264325
• Other study ID #: 7565
• Status: Completed
• Start date: January 31, 2020
• Est. completion date: May 3, 2023

Study information

• Verified date: May 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 3, 2023
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Other:
• diaphragmatic ultrasound measure
patients with lung neoplasms and malignant pleural effusions who need a diagnostic or therapeutic thoracocentesis

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the feasibility of measuring the diaphragmatic amplitude in wide breathing (RA) on the side homolateral to the pleural puncture	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.	one day
Secondary	Feasability of quiet breath inspiratory motion	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.	one day