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

Phase 2

Completed

• Conditions: Consciousness Disorders; Wearing Off Effect; Artificial Respiration
• Interventions: Procedure: mechanical ventilation

• Registration Number: NCT00700869
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-18
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	mechanical ventilation	Tracheal tube withdrawal governs by respiratory behaviour status

Primary Outcome Measures

Name	Time	Method
Rate of successful mechanical ventilation weaning at 72 hours	72 hours

Secondary Outcome Measures

Name	Time	Method
Post tracheal tube withdrawal pneumonia at 72 hours	72 hours
Rate of auto-extubation during patient's participation to the protocol	10 days

Trial Locations

Locations (1)

Anesthesia and CCM; Lariboisière Hospital; 🇫🇷 Paris, France