Clinical trial NCT00700869: Evaluation of a New Mechanical Ventilation Weaning Strategy for Patients With Altered Level of Consciousness
Official title: Phase 2 Study of a New Mechanical Ventilation Weaning Strategy Governs by a Respiratory Behaviour Status Assessment for Patients With Altered Level of Consciousness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Artificial Respiration
Consciousness Disorders
Wearing Off Effect
Keywords: Altered level of consciousness
Tracheal tube withdrawal
Respiration
Artificial Respiration
Physiology
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-06-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of successful mechanical ventilation weaning at 72 hours
timeFrame: 72 hours
Secondary outcomes:
measure: Post tracheal tube withdrawal pneumonia at 72 hours
timeFrame: 72 hours
measure: Rate of auto-extubation during patient's participation to the protocol
timeFrame: 10 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Anesthesia and CCM; Lariboisière Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Laurent HEYER, MD
role: PRINCIPAL_INVESTIGATOR
References: