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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05415605
Collaborator
(none)
30
1
1
2.2
13.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Lung Strain
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Ultrasound Evaluation of Alveolar Stress by Measurement of Ultrasound Pleural Strain in Healthy Subjects
Anticipated Study Start Date :
Jul 24, 2022
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Lung Strain values [during the procedure (30 min)]

    Lung strain values (%) in spontaneous ventilation and then under non-invasive mechanical ventilation (NIV) by varying tidal volume and PEEP

Secondary Outcome Measures

  1. Ultrasound semiology and normal values [during the procedure (30 min)]

    Description of the ultrasound semiology and the normal values of the different strain parameters (Global longitudinal strain and strain rate) during apnea

  2. Variations of the strain under NIV in the different pulmonary zones tested [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 in the different pulmonary zones tested

  3. Longitudinal and transversal values of lung strain in the different pulmonary zones tested [during the procedure (30 min)]

    Description of the longitudinal and transversal values of the lung strain and lung strain rate in the different pulmonary zones tested

  4. 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

  5. Variations of the strain under NIV of the diaphragm [during the procedure (30 min)]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nîmes, Hôpital Universitaire Carémeau Nîmes France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT05415605
Other Study ID Numbers:
  • LOCAL/2019/LM-01
First Posted:
Jun 13, 2022
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Nīmes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 13, 2022