Deformation of the Diaphragm Zone of Apposition

NCT04424277 | Completed

• 1 other identifier: ZADSPECTRA
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Physiology

Keywords

diaphragm; ultrasound

Outcome Measures

Primary Outcomes (1)

• Coefficient of reproducibility

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

  1 hour

Secondary Outcomes (5)

• agreement between the strain and pressure time product of diaphragm (PTPdi)

  1 hour

• agreement between the strain rate of the PTPdi

  1 hour

• comparison of repeatability and reproducibility of the various ultrasound indices (TEE, TFdi, ε and ε ').

  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

• Exploration of the link between the deformation of the accessory respiratory muscles by speckle tracking and the PTPdi

  1 hour

Interventions

diaphragm ultrasound OTHER

respiratory loading

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The subjects and participants will be contacted individually by the investigators. The principles of the study will be explained and explained to the volunteer.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Saint Joseph Saint Luc de Lyon: lead

Study Sites (1)

Groupe CARMAS

Créteil, Val De Marne, 94440, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: June 9, 2020
• Study Start: March 14, 2019
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 9, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)