Ultrasound Strain MeasurementLUNGSTRAINNCT05415605
Ultrasound Evaluation of Alveolar Stress by Measurement of Ultrasound Pleural Strain in Healthy Subjects
A study testing Lung Strain in people with Ultrasound Strain Measurement, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Strain Measurement
- What is being tested?
- Lung Strain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2022to 27 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Healthy volunteer male or female between 18 and 50 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Lung Strain
- Keywords
- lung strain, speckle tracking, lung stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung StrainDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| healthy Volunteers | Experimental | Healthy male or female volunteers between 18 and 50 years old Receives: Device: Lung Strain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Strain values
Lung strain values (%) in spontaneous ventilation and then under non-invasive mechanical ventilation (NIV) by varying tidal volume and PEEP
Measured: during the procedure (30 minutes)
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: during the procedure (30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start24 Jul 2022
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ultrasound Strain MeasurementStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415605
- Sponsor's protocol ID
- LOCAL/2019/LM-01
- Other IDs
- 2019-A01407-50
- Acronym
- LUNGSTRAIN
- Status last verified
- Aug 2022
- First submitted
- 9 Jun 2022
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38968827
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of Alveolar Stress by Measurement of Ultrasound Pleural Strain in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05415605
- Acronym / sponsor ID
- LUNGSTRAIN / LOCAL/2019/LM-01
- Conditions
- Ultrasound Strain Measurement
- Keywords
- lung strain, speckle tracking, lung stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 24 Jul 2022 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy Volunteers | Experimental | Device: Lung StrainHealthy male or female volunteers between 18 and 50 years old |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Healthy volunteer male or female between 18 and 50 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung StrainThe 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. | Device | healthy Volunteers |
Primary outcome
Lung Strain values
Time frame: 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
5 secondary outcomes
Ultrasound semiology and normal values
Time frame: during the procedure (30 minutes)
Variations of the strain under NIV in the different pulmonary zones tested
Time frame: during the procedure (30 minutes)
Longitudinal and transversal values of lung strain in the different pulmonary zones tested
Time frame: during the procedure (30 minutes)
Variations of the strain under NIV in the right ventricle
Time frame: during the procedure (30 min)
Variations of the strain under NIV of the diaphragm
Time frame: during the procedure (30 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 38968827Duclos 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Strain in people with Ultrasound Strain Measurement, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Strain values (time frame: during the procedure (30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05415605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.