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Completed

NCT Number: NCT04424277

Deformation of the Diaphragm Zone of Apposition

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).

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Key information

Conditions

Respiratory Physiology

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe CARMAS

Créteil, Val De Marne, 94440, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diaphragm ultrasound

Other

respiratory loading

Primary outcomes

  1. Coefficient of reproducibility

    Time frame: 1 hour

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

Secondary outcomes

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

    Time frame: 1 hour

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

  2. agreement between the strain rate of the PTPdi

    Time frame: 1 hour

    Correlation between the strain rate of the PTPdi

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

    Time frame: 1 hour

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

  4. 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.

    Time frame: 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.

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

    Time frame: 1 hour

    Coorelatin between strain of the accessory respiratory muscles and the PTPdi

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Other

Registry information

Official study 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

Acronym: ZADSPECTRA

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 9, 2020
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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