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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04424277
Acronym
ZADSPECTRA
Enrollment
17
Registered
2020-06-09
Start date
2019-03-14
Completion date
2019-12-31
Last updated
2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Physiology

Keywords

diaphragm, ultrasound

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.

Interventions

respiratory loading

Sponsors

Centre Hospitalier Saint Joseph Saint Luc de Lyon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Coefficient of reproducibility1 hourreproducibility and repetability measurments of strain (ε) and strain rate (ε') .

Secondary

MeasureTime frameDescription
agreement between the strain and pressure time product of diaphragm (PTPdi)1 hourCorrelation between the strain and pressure time product of diaphragm (PTPdi)
agreement between the strain rate of the PTPdi1 hourCorrelation between the strain rate of the PTPdi
comparison of repeatability and reproducibility of the various ultrasound indices (TEE, TFdi, ε and ε ').1 hourComparison of repeatability and reproducibility of the various ultrasound indices (TEE, TFdi, ε and ε ').
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 hourRepeatability 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.
Exploration of the link between the deformation of the accessory respiratory muscles by speckle tracking and the PTPdi1 hourCoorelatin between strain of the accessory respiratory muscles and the PTPdi

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026