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

NCT ID: NCT00700869

Last Updated: 2011-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-09-30

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.

Conditions

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Artificial Respiration Consciousness Disorders Wearing Off Effect

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Tracheal tube withdrawal governs by respiratory behaviour status

Group Type EXPERIMENTAL

mechanical ventilation

Intervention Type PROCEDURE

mechanical ventilation

Interventions

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mechanical ventilation

mechanical ventilation

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent HEYER, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Anesthesia and CCM; Lariboisière Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P070204

Identifier Type: -

Identifier Source: org_study_id