Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation

Study Overview
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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.

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

Conditions
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Mechanical Ventilation Weaning

Intervention / Treatment
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* Procedure: Diaphragmatic ultrasound


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br> | Procedure: Diaphragmatic ultrasound<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation success rate | Extubation success rate, defined as no reintubation 7 days after the reporting extubation | 7 days after the reported extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in reanimation unit (days) |  | At discharge of reanimation unit (up to 1 year) | 
| Length of mechanical ventilation |  | At the extubation time | 
| Number of patients with invasive or non-invasive mechanical ventilation | Resort to invasive or non-invasive mechanical ventilation | 48 hours after the extubation | 
| Mortality |  | 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 | 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 | 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 |  | 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 |  | At the extubation time | 
| Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : maximal inspiratory pressure in centimeters of water |  | 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 |  | 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) |  | 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) |  | At the extubation time | 
| Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : P0,1 measured in milliseconds |  | At the extubation time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diaphragmatic dysfunction, mechanical ventilation weaning, failure extubation rate