Ultrasound Evaluation of Alveolar Stress by Measurement of Ultrasound Pleural Strain in Healthy Subjects (LUNGSTRAIN)
Primary Purpose
Ultrasound Strain Measurement
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lung Strain
Sponsored by
About this trial
This is an interventional other trial for Ultrasound Strain Measurement focused on measuring lung strain, speckle tracking, lung stress
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
Sites / Locations
- CHU de Nîmes, Hôpital Universitaire Carémeau
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
healthy Volunteers
Arm Description
Healthy male or female volunteers between 18 and 50 years old
Outcomes
Primary Outcome Measures
Lung Strain values
Lung strain values (%) in spontaneous ventilation and then under non-invasive mechanical ventilation (NIV) by varying tidal volume and PEEP
Secondary Outcome Measures
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
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
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
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
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
Full Information
NCT ID
NCT05415605
First Posted
June 9, 2022
Last Updated
August 31, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT05415605
Brief Title
Ultrasound Evaluation of Alveolar Stress by Measurement of Ultrasound Pleural Strain in Healthy Subjects
Acronym
LUNGSTRAIN
Official Title
Ultrasound Evaluation of Alveolar Stress by Measurement of Ultrasound Pleural Strain in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 24, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ultrasound Strain Measurement
Keywords
lung strain, speckle tracking, lung stress
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
healthy Volunteers
Arm Type
Experimental
Arm Description
Healthy male or female volunteers between 18 and 50 years old
Intervention Type
Device
Intervention Name(s)
Lung Strain
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lung Strain values
Description
Lung strain values (%) in spontaneous ventilation and then under non-invasive mechanical ventilation (NIV) by varying tidal volume and PEEP
Time Frame
during the procedure (30 minutes)
Secondary Outcome Measure Information:
Title
Ultrasound semiology and normal values
Description
Description of the ultrasound semiology and the normal values of the different strain parameters (Global longitudinal strain and strain rate) during apnea
Time Frame
during the procedure (30 minutes)
Title
Variations of the strain under NIV in the different pulmonary zones tested
Description
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
Time Frame
during the procedure (30 minutes)
Title
Longitudinal and transversal values of lung strain in the different pulmonary zones tested
Description
Description of the longitudinal and transversal values of the lung strain and lung strain rate in the different pulmonary zones tested
Time Frame
during the procedure (30 minutes)
Title
Variations of the strain under NIV in the right ventricle
Description
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
Time Frame
during the procedure (30 min)
Title
Variations of the strain under NIV of the diaphragm
Description
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
Time Frame
during the procedure (30 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
CHU de Nîmes, Hôpital Universitaire Carémeau
City
Nîmes
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultrasound Evaluation of Alveolar Stress by Measurement of Ultrasound Pleural Strain in Healthy Subjects
We'll reach out to this number within 24 hrs