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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3; Phase 2

Conditions: Wearing Off Effect; Artificial Respiration; Consciousness Disorders

Treatments: Procedure: mechanical ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT00700869

P070204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

1

Experimental group

Description:

Tracheal tube withdrawal governs by respiratory behaviour status

Treatment:

Procedure: mechanical ventilation