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

Not Applicable

Completed

• Conditions: Ultrasound Strain Measurement
• Interventions: Device: Lung Strain

• Registration Number: NCT05415605
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-13
• Study Start: 2022-07-24
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
healthy Volunteers	Lung Strain	Healthy male or female volunteers between 18 and 50 years old

Primary Outcome Measures

Name	Time	Method
Lung Strain values	during the procedure (30 minutes)	Lung strain values (%) in spontaneous ventilation and then under non-invasive mechanical ventilation (NIV) by varying tidal volume and PEEP

Secondary Outcome Measures

Name	Time	Method
Variations of the strain under NIV in the different pulmonary zones tested	during the procedure (30 minutes)	Description of the variations of the strain and strain rate (inspiratory and expiratory) according to the variations of the level of inspiratory support and positive expiratory pressure (PEEP) under NIV in the different pulmonary zones tested
Variations of the strain under NIV in the right ventricle	during the procedure (30 min)	Description of the variations of the strain and strain rate (inspiratory and expiratory) according to the variations of the level of inspiratory support and positive expiratory pressure (PEEP) under NIV of the right ventricle
Variations of the strain under NIV of the diaphragm	during the procedure (30 minutes)	Description of the variations of the strain and strain rate (inspiratory and expiratory) of the diaphragm according to the variations of the level of inspiratory support and positive expiratory pressure (PEEP) under NIV. The evaluation of the diaphragmatic strain will be coupled and compared to the fraction of shortening of the diaphragm, which is currently the ultrasound reference method to measure the function of this muscle
Ultrasound semiology and normal values	during the procedure (30 minutes)	Description of the ultrasound semiology and the normal values of the different strain parameters (Global longitudinal strain and strain rate) during apnea
Longitudinal and transversal values of lung strain in the different pulmonary zones tested	during the procedure (30 minutes)	Description of the longitudinal and transversal values of the lung strain and lung strain rate in the different pulmonary zones tested

Trial Locations

Locations (1)

CHU de Nîmes, Hôpital Universitaire Carémeau; 🇫🇷 Nîmes, France