Diaphragmatic Atrophy Related to Mechanical Ventilation

Study Overview
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Brief Summary
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Ventilatory support during critical phase result in inactivity of respiratory muscles especially diaphragm muscle. These inactivity also result in change of contractile capability and quick muscular atrophy. The aim of the study is to visualize the evolution of diaphragm thickness by echography during Mechanical Ventilation for patients with septic shock or acute respiratory distress syndrome and to compare with the evolution for patients under non-invasive ventilation and those with spontaneous ventilation. Measurements will be performed at day 1, day 5 and day 10 (if patient still under a mode of ventilation or in the unit). The evolution of diaphragm thickness will also be compared to pectoralis muscle atrophy, which is not involved in ventilation, in order to assess respective effect of ventilatory inactivity and undernutrition linked to intensive care.

Official Title
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Ultrasound Observation of Diaphragmatic Atrophy Related to Mechanical Ventilation A Prospective Monocentric Study in Intensive Care Unit

Conditions
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Septic Shock, Acute Respiratory Distress

Intervention / Treatment
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* Device: Ultrasound
* Device: Ultrasound
* Other: Neuromyopathy score
* Other: Respiratory performances


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old Group 1 : under Mechanical Ventilation (time of Mechanical Ventilation for at least 5 days) Group 2 : under Non-invasive Ventilation Group 3 : Spontaneous Ventilation Non opposition of patient (Groups 2 and 3) or non-opposition of patient family member (Group 1) Exclusion Criteria: Known diaphragmatic paralysis Neurologic pathology with motor deficit Pregnancy or breast-feeding woman

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

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mechanical Ventilation<br>Evolution over time of Diaphragmatic and Pectoralis muscle atrophy under Mechanical Ventilation Interventions : Ultrasound of the right diaphragm Ultrasound of the pectoral muscle Neuromyopathy score Respiratory performances | Device: Ultrasound<br>* An ultrasound of the right diaphragm will be performed on day 1, day 3, day 5 and day 10<br>Device: Ultrasound<br>* An ultrasound of the pectoral muscle will be performed on day 1, day 3, day 5 and day 10<br>Other: Neuromyopathy score<br>* A neuromyopathy score will be assessed on the extubation day<br>Other: Respiratory performances<br>* An assessment of the respiratory performances will be done on the extubation day, including higher expiratory pressure, higher inspiratory pressure, and occlusion pressure<br>|
| Active Comparator: Non-invasive Ventilation<br>Evolution over time of Diaphragmatic and Pectoralis muscle atrophy under Non-invasive Ventilation Interventions : Ultrasound of the right diaphragm Ultrasound of the pectoral muscle Neuromyopathy score Respiratory performances | Device: Ultrasound<br>* An ultrasound of the right diaphragm will be performed on day 1, day 3, day 5 and day 10<br>Device: Ultrasound<br>* An ultrasound of the pectoral muscle will be performed on day 1, day 3, day 5 and day 10<br>Other: Neuromyopathy score<br>* A neuromyopathy score will be assessed on the extubation day<br>Other: Respiratory performances<br>* An assessment of the respiratory performances will be done on the extubation day, including higher expiratory pressure, higher inspiratory pressure, and occlusion pressure<br>|
| Active Comparator: Spontaneous Ventilation<br>Evolution over time of Diaphragmatic and Pectoralis muscle atrophy under Spontaneous Ventilation Interventions : Ultrasound of the right diaphragm Ultrasound of the pectoral muscle Neuromyopathy score Respiratory performances | Device: Ultrasound<br>* An ultrasound of the right diaphragm will be performed on day 1, day 3, day 5 and day 10<br>Device: Ultrasound<br>* An ultrasound of the pectoral muscle will be performed on day 1, day 3, day 5 and day 10<br>Other: Neuromyopathy score<br>* A neuromyopathy score will be assessed on the extubation day<br>Other: Respiratory performances<br>* An assessment of the respiratory performances will be done on the extubation day, including higher expiratory pressure, higher inspiratory pressure, and occlusion pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from day 1 diaphragm thickness at day 3 and day 5 | Diaphragm thickness measured by ultrasound | 1 day, 3 days and 5 days after introduction of Mechanical Ventilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm thickness measured by ultrasound |  | 10 days after introduction of Mechanical Ventilation | 
| Type of ventilatory support | Define which type of ventilatory support is used (mechanical ventilation, non-invasive ventilation, or spontaneous ventilation) | 10 days after start of ventilatory support | 
| Ventilatory mode | Ventilatory mode (controlled ventilation, pressure support ventilation) | 10 days after start of ventilatory support | 
| Pectoralis muscle thickness measured by ultrasound | To compare the importance of this atrophy to those of diaphragmatic muscle | 10 days after start of ventilatory support | 
| Diaphragmatic strength | Relation between diaphragmatic atrophy and decrease of diaphragmatic strength | intraoperative | 
| Early or late extubation failure rate (extubation performed before or after 48 hours) | Relation between diaphragmatic atrophy importance and premature (<48h) or late extubation failure | The last day of hospitalisation | 
| MRC score (Medical Research Council) | Relation between diaphragmatic atrophy and decrease of diaphragmatic strength | intraoperative | 
| Length of ventilation in hours |  | 10 days after start of ventilatory support | 
| Drug administration | Presence of drug administration such as curare, corticoid or sedative. If yes : number of days with treatment | 10 days after start of ventilatory support | 
| Total positive end expiratory pressure |  | 10 days after start of ventilatory support | 
| External positive end expiratory pressure |  | 10 days after start of ventilatory support | 
| Respiratory rate |  | 10 days after start of ventilatory support | 
| Highest inspiratory pressure level |  | 10 days after start of ventilatory support | 
| Highest expiratory pressure level |  | 10 days after start of ventilatory support | 
| Volume of exhaled air |  | 10 days after start of ventilatory support | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical Ventilation