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Clinical Trials/NCT04424277
NCT04424277
Completed
Not Applicable

Deformation of the Diaphragm Zone of Apposition During the Loading of the Respiratory System in the Healthy Volunteer. Evaluation of a New Index Measured by Speckle Tracking

Centre Hospitalier Saint Joseph Saint Luc de Lyon1 site in 1 country17 target enrollmentMarch 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Physiology
Sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Enrollment
17
Locations
1
Primary Endpoint
Coefficient of reproducibility
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The assessment of the work of the respiratory muscles is a fundamental clinical data in intensive care, especially to guide the management of patients requiring ventilatory support. This data is difficult to access in current practice. The reference technique to estimate the work of breathing (transdiaphragmatic pressure) is not feasible in clinical routine and evaluates only the respiratory work of the diaphragm, not that of the accessory muscles. The ultrasound technique of speckle tracking allows a fine and multidimensional analysis of the deformation of the respiratory muscles during the respiratory cycle.

The investigators hypothesize that the analysis of the multidimensional deformation of the diaphragm at the level of the apposition zone can produce a robust and reproducible index, which is correlated with the work of breathing. The performance of this index will be compared to that of the thickening fraction of the diaphragm. On the other hand, the investigators will evaluate the feasibility of measuring the thickening of the accessory respiratory muscles (scalene and intercostal).

Detailed Description

Fifteen healthy subjects will be equipped with a double-balloon esophagogastric tube and subjected to increasing and gradual loading of the respiratory system by a negative-pressure inspiration device. The respiratory work will be recorded continuously by measuring the transdiaphragmatic pressure (reference technique). The recording of the deformation of the diaphragmatic apposition zone by speckle tracking technique will make it possible to define a multi-dimensional deformation index of this muscular portion. The reproducibility and the repeatability of this index will be evaluated then this index will be compared to the reference technique, as well as to the fraction of thickening. The deformation of the accessory muscles will also be evaluated in a second step.

Registry
clinicaltrials.gov
Start Date
March 14, 2019
End Date
December 31, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy volunteer (male or female)
  • Free and informed consent

Exclusion Criteria

  • known pregnancy, parturient or nursing mother
  • Under 18 years old
  • Age\> 45 years
  • Incapable major
  • Non-affiliation to the social security system
  • Any history of respiratory pathology
  • Any history of coagulation disorder or platelet function

Outcomes

Primary Outcomes

Coefficient of reproducibility

Time Frame: 1 hour

reproducibility and repetability measurments of strain (ε) and strain rate (ε') .

Secondary Outcomes

  • comparison of repeatability and reproducibility of the various ultrasound indices (TEE, TFdi, ε and ε ').(1 hour)
  • Exploration of the link between the deformation of the accessory respiratory muscles by speckle tracking and the PTPdi(1 hour)
  • agreement between the strain and pressure time product of diaphragm (PTPdi)(1 hour)
  • agreement between the strain rate of the PTPdi(1 hour)
  • Repeatability and reproducibility of the measurement of the deformation (ε) and the rate of deformation (ε ') of the accessory muscles (scalene then intercostal) subjected to variable inspiratory loads.(1 hour)

Study Sites (1)

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