Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation (ECHODIAPH II)

April 3, 2024 updated by: Centre Hospitalier Saint Joseph Saint Luc de Lyon

Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation and Influence Over Mechanical Ventilation Weaning Period

Extubation is a crucial step when patients are being weaned from mechanical ventilator support. Indeed, the patient has to face an increasing burden imposed to the ventilation system. The ability to overcome this event will determine the patient survival. A warning signal could be very useful is this situation. 2 recent studies have shown that measuring diaphragmatic cupolas and muscular fibers thickening fraction could help to spot a population with a high risk of "diaphragmatic weakness", characterized by a high failure extubation rate. This study aims to verify that this kind of group of patients does exist.

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.

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.
Interventional

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.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69007
        • Centre Hospitalier Saint Joseph Saint Luc
      • Metz-Tessy, France, 74374
        • Centre Hospitalier Annecy Genevois
      • Poitiers, France, 86021
        • Centre Hospitalier Universitaire de Poitiers

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Successful spontaneous breathing trial and extubation expected on the same day and 1 of the following criteria :
  • Age > 65
  • Mechanical ventilation during > 7 days
  • Cardiac history (ischemic, rhythmic or valve cardiopathy)
  • Respiratory history (documented or likely chronic respiratory failure)

Exclusion Criteria:

  • Patient who is tracheotomized
  • Peripheric neuromuscular disease (myasthenia, myopathy)
  • Surgery circumstances that could affect the quality of the ultrasound exam (drains or bandages)
  • Pregnant woman
  • Age < 18

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Other: Single arm
Procedure: Diaphragmatic ultrasound

All patients will have a diaphragmatic ultrasound in the 4 hours before the extubation.

  • a record of the right and left diaphragmatic cupolas run, with a chest approach and using a 4-5 MHz (megahertz) cardiac or abdominal sensor. 3 acquisitions for each side
  • a record of the diaphragm thickening at the right and left apposition zones with a 10-12 MHz (megahertz) vascular sensor. 3 acquisitions for each side

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
Extubation success rate
Time Frame: 7 days after the reported extubation
Extubation success rate, defined as no reintubation 7 days after the reporting extubation
7 days after the reported extubation

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
Length of stay in reanimation unit (days)
Time Frame: At discharge of reanimation unit (up to 1 year)
At discharge of reanimation unit (up to 1 year)
Length of mechanical ventilation
Time Frame: At the extubation time
At the extubation time
Number of patients with invasive or non-invasive mechanical ventilation
Time Frame: 48 hours after the extubation
Resort to invasive or non-invasive mechanical ventilation
48 hours after the extubation
Mortality
Time Frame: At discharge of reanimation unit (up to 1 year)
At discharge of reanimation unit (up to 1 year)
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : cough strength measured with a defined scale
Time Frame: At the extubation time

The scale used to measure the cough is the following :

  • absent
  • inefficient
  • low efficiency
  • mild efficiency
  • efficient
At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : quantity of secretions measured with a defined scale
Time Frame: At the extubation time
  • any secretions
  • low secretions
  • mild secretions
  • abundant secretions
  • very abundant secretions
At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : presence/absence or cervical tonus
Time Frame: At the extubation time
At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : F/Vt ratio measured in breaths/min/L
Time Frame: At the extubation time
At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : maximal inspiratory pressure in centimeters of water
Time Frame: At the extubation time
At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : minimal expiratory pressure measured in centimeters of water
Time Frame: At the extubation time
At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : peak flow measured in L/min (liters per minute)
Time Frame: At the extubation time
At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : peak flow when coughing measured in L/min (liters per minute)
Time Frame: At the extubation time
At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : P0,1 measured in milliseconds
Time Frame: At the extubation time
At the extubation time

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Poitiers University Hospital

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 6, 2015

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 28, 2016

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.
November 1, 2016

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).
May 27, 2016

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.
August 25, 2016

First Posted (Estimated)

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.
August 30, 2016

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.
April 4, 2024

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.
April 3, 2024

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.
April 1, 2024

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.
  • SJSL12014

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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