Deformation of the Diaphragm Zone of Apposition

Respiratory Physiology Clinical Trial

— ZADSPECTRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424277
• Other study ID #: ZADSPECTRA
• Status: Completed
• Start date: March 14, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2019
• Source: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Physiology

Intervention

Other:
• diaphragm ultrasound
respiratory loading

Locations

Country	Name	City	State
France	Groupe CARMAS	Créteil	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Saint Joseph Saint Luc de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coefficient of reproducibility	reproducibility and repetability measurments of strain (e) and strain rate (e') .	1 hour
Secondary	agreement between the strain and pressure time product of diaphragm (PTPdi)	Correlation between the strain and pressure time product of diaphragm (PTPdi)	1 hour
Secondary	agreement between the strain rate of the PTPdi	Correlation between the strain rate of the PTPdi	1 hour
Secondary	comparison of repeatability and reproducibility of the various ultrasound indices (TEE, TFdi, e and e ').	Comparison of repeatability and reproducibility of the various ultrasound indices (TEE, TFdi, e and e ').	1 hour
Secondary	Repeatability and reproducibility of the measurement of the deformation (e) and the rate of deformation (e ') of the accessory muscles (scalene then intercostal) subjected to variable inspiratory loads.	Repeatability and reproducibility of the measurement of the deformation (e) and the rate of deformation (e ') of the accessory muscles (scalene then intercostal) subjected to variable inspiratory loads.	1 hour
Secondary	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