Evaluation of a New Mechanical Ventilation Weaning Strategy for Patients With Altered Level of Consciousness

Study Overview
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Brief Summary
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The purpose of this study is to determine if a weaning strategy from artificial ventilation governs by respiratory behaviour status assessed by our method is safe enough.

Detailed Description
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Current guidelines for mechanical ventilation weaning do not apply for patients with altered level of consciousness. One major limitation is a failure of clinical assessment of the respiratory behaviour status of these patients that are not able to interact appropriately with the examiner. We propose a non-invasive method for the respiratory behaviour assessment of a patient under artificial ventilation that do not requires his participation. Our hypothesis is that, in case of normal respiratory behaviour status, it is possible to wean under security a patient despite his abnormal level of consciousness.We previously demonstrate that patients successfully wean by the clinical team also disclose a normal respiratory behaviour status while patients with weaning failure had abnormal respiratory behaviour. In the present study, we wonder to evaluate that a weaning strategy governs by respiratory behaviour status assessed by our method is safe. For this purpose, in this study, tracheal tube withdrawal is triggered by a recognition of a normal respiratory behaviour status assessed daily in patients under mechanical ventilation with an altered level of consciousness and a good tolerance to T tube challenge.

Official Title
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Phase 2 Study of a New Mechanical Ventilation Weaning Strategy Governs by a Respiratory Behaviour Status Assessment for Patients With Altered Level of Consciousness

Conditions
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Artificial Respiration, Consciousness Disorders, Wearing Off Effect

Intervention / Treatment
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* Procedure: mechanical ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Altered level of consciousness (-1 < RASS > +1) Mechanical ventilation ( > 72 hours) Withdrawal of sedative drugs (> 48 hours) T tube challenge tolerance Signed approval for the study by close relative or legal representative Exclusion Criteria: Respiratory disease prior to the actual artificial ventilation requirement. Impairment of upper airway function prior to the actual artificial ventilation requirement. Pregnancy Minor

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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Tracheal tube withdrawal governs by respiratory behaviour status | Procedure: mechanical ventilation<br>* mechanical ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful mechanical ventilation weaning at 72 hours |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post tracheal tube withdrawal pneumonia at 72 hours |  | 72 hours | 
| Rate of auto-extubation during patient's participation to the protocol |  | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Altered level of consciousness, Tracheal tube withdrawal, Respiration, Artificial Respiration, Physiology