Ultrasound Evaluation of Alveolar Stress by Measurement of Ultrasound Pleural Strain in Healthy Subjects

NCT ID: NCT05415605

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-24
• Study Completion Date: 2022-07-27

Brief Summary

In the critical patient, lung ultrasound is routinely performed for acute respiratory distress, adult respiratory distress syndrome and for hemodynamic evaluation. Its diagnostic performance is superior to that of chest radiography in the context of pleuropulmonary parenchymal pathologies. The search for lung sliding is performed to diagnose a pneumothorax or to search for the correct placement of the endotracheal intubation tube. However, this analysis is qualitative and is sometimes difficult to interpret. At present, there is no global evaluation technique at the patient's bed allowing to analyze simultaneously the alveolar recruitment, the pulmonary over-distension and the quality of the lung sliding, whereas the pulmonary damage is most often heterogeneous. The justification of our research project is based on the need to develop and validate a means of global and regional quantification of the mechanical and aeration properties of the lung parenchyma by the analysis of the acoustic markers of the pleura (pleural strain) by the ultrasound technique of speckle tracking. The aim is to establish the normal values of the pleural strain in healthy volunteers, in spontaneous ventilation and then in non-invasive mechanical ventilation, in order to vary the lung volume.

Conditions

Ultrasound Strain Measurement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

healthy Volunteers

Healthy male or female volunteers between 18 and 50 years old

Group Type: EXPERIMENTAL

Lung Strain

Intervention Type: DEVICE

The main objective of this study is to describe the physiological values of lung strain in healthy volunteers as well as its variations induced by non-invasive positive pressure ventilation and their correlation with tidal volume.

Interventions

Lung Strain

The main objective of this study is to describe the physiological values of lung strain in healthy volunteers as well as its variations induced by non-invasive positive pressure ventilation and their correlation with tidal volume.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

-Healthy volunteer male or female between 18 and 50 years old

Exclusion Criteria

• History of traumatic or spontaneous pneumothorax
• History of connective tissue disease
• Any history of chronic respiratory disease
• Presence of an ongoing clinical respiratory Ear-Nose-Throat (ENT) or pulmonary syndrome (rhinitis, sinusitis, bronchitis, lung disease)
• History of gastro-duodenal reflux or stomach surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Nîmes, Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

References

Duclos G, Marecal L, Resseguier N, Postzich M, Taguet C, Hraiech S, Leone M, Muller L, Zieleskiewicz L. Pleural lung sliding quantification using a speckle tracking technology: A feasibility study on 30 healthy volunteers. Comput Methods Programs Biomed. 2024 Sep;254:108316. doi: 10.1016/j.cmpb.2024.108316. Epub 2024 Jul 2.

Reference Type: RESULT

PMID: 38968827 (View on PubMed)

Other Identifiers

2019-A01407-50

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2019/LM-01

Identifier Type: -

Identifier Source: org_study_id