Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation

NCT ID: NCT02883465

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-06

Study Completion Date

2016-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Mechanical Ventilation Weaning

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm

Group Type OTHER

Diaphragmatic ultrasound

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role collaborator

Centre Hospitalier Saint Joseph Saint Luc de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Saint Joseph Saint Luc

Lyon, , France

Site Status

Centre Hospitalier Annecy Genevois

Metz-Tessy, , France

Site Status

Centre Hospitalier Universitaire de Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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SJSL12014

Identifier Type: -

Identifier Source: org_study_id

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