Clinical Trials Directory

Trials / Completed

CompletedNCT04424277

Deformation of the Diaphragm Zone of Apposition

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

Status
Completed
Phase
Study type
Observational
Enrollment
17 (actual)
Sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERdiaphragm ultrasoundrespiratory loading

Timeline

Start date
2019-03-14
Primary completion
2019-10-31
Completion
2019-12-31
First posted
2020-06-09
Last updated
2020-06-09

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04424277. Inclusion in this directory is not an endorsement.

Deformation of the Diaphragm Zone of Apposition (NCT04424277) · Clinical Trials Directory