Deformation of the Diaphragm Zone of Apposition (ZADSPECTRA)

June 5, 2020 updated by: Centre Hospitalier Saint Joseph Saint Luc de Lyon

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Coefficient of reproducibility
Time Frame: 1 hour
reproducibility and repetability measurments of strain (ε) and strain rate (ε') .
1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
1 hour
agreement between the strain rate of the PTPdi
Time Frame: 1 hour
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 ').
Time Frame: 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.
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.
1 hour
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
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Saint Joseph Saint Luc de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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