Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions : A Feasability Study

NCT04264325 | Completed

• 1 other identifier: 7565
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Pleural Effusion; Lung Neoplasms

Keywords

Dyspnea; Malignant pleural effusion; Lung Neoplasms; Therapeutic thoracocentesis; Lung ultrasound; Diaphragmatic ultrasound; Diaphragmatic dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Feasability of quiet breath inspiratory motion

  one day

Study Arms (1)

Malignant pleural effusions : diaphragmatic ultrasound measure

Other: diaphragmatic ultrasound measure

Interventions

diaphragmatic ultrasound measure OTHER

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

Malignant pleural effusions : diaphragmatic ultrasound measure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant; Lung Neoplasms; Dyspnea

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mickaël OHANA

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 11, 2020
• Study Start: January 31, 2020
• Primary Completion: August 20, 2020
• Study Completion: May 3, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

FR (1)