Deformation of the Diaphragm Zone of Apposition (ZADSPECTRA)

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

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).

Study Overview

• Status: Completed
• Conditions: Respiratory Physiology
• Intervention / Treatment: Other: diaphragm ultrasound

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.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• France
  • Val De Marne
    • Créteil, Val De Marne, France, 94440
      • Groupe CARMAS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coefficient of reproducibility	reproducibility and repetability measurments of strain (ε) and strain rate (ε') .	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
agreement between the strain and pressure time product of diaphragm (PTPdi)	Correlation between the strain and pressure time product of diaphragm (PTPdi)	1 hour
agreement between the strain rate of the PTPdi	Correlation between the strain rate of the PTPdi	1 hour
comparison of repeatability and reproducibility of the various ultrasound indices (TEE, TFdi, ε and ε ').	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.	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	Coorelatin between strain of the accessory respiratory muscles and the PTPdi	1 hour

Collaborators and Investigators

• Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 14, 2019
• Primary Completion (ACTUAL): October 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: ultrasound; diaphragm
• Other Study ID Numbers: ZADSPECTRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No