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

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.

Study Overview

• Status: Completed
• Conditions: Ultrasound Strain Measurement
• Intervention / Treatment: Device: Lung Strain

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHU de Nîmes, Hôpital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: healthy Volunteers; Healthy male or female volunteers between 18 and 50 years old	Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound semiology and normal values	Description of the ultrasound semiology and the normal values of the different strain parameters (Global longitudinal strain and strain rate) during apnea	during the procedure (30 minutes)
Variations of the strain under NIV in the different pulmonary zones tested	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	during the procedure (30 minutes)
Longitudinal and transversal values of lung strain in the different pulmonary zones tested	Description of the longitudinal and transversal values of the lung strain and lung strain rate in the different pulmonary zones tested	during the procedure (30 minutes)
Variations of the strain under NIV in the right ventricle	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	during the procedure (30 min)
Variations of the strain under NIV of the diaphragm	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	during the procedure (30 minutes)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2022
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: speckle tracking; lung strain; lung stress
• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains
• Other Study ID Numbers: LOCAL/2019/LM-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No