Deformation of the Diaphragm Zone of Apposition

NCT ID: NCT04424277

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-14
• Study Completion Date: 2019-12-31

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.

Conditions

Respiratory Physiology

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Interventions

diaphragm ultrasound

respiratory loading

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Saint Joseph Saint Luc de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Groupe CARMAS

Créteil, Val De Marne, France

Countries

France

Other Identifiers

ZADSPECTRA

Identifier Type: -

Identifier Source: org_study_id