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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00700869
Acronym
ORGAR
Enrollment
34
Registered
2008-06-19
Start date
2008-04-30
Completion date
2011-09-30
Last updated
2011-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Respiration, Consciousness Disorders, Wearing Off Effect

Keywords

Altered level of consciousness, Tracheal tube withdrawal, Respiration, Artificial Respiration, Physiology

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.

Interventions

PROCEDUREmechanical ventilation

mechanical ventilation

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Rate of successful mechanical ventilation weaning at 72 hours72 hours

Secondary

MeasureTime frame
Post tracheal tube withdrawal pneumonia at 72 hours72 hours
Rate of auto-extubation during patient's participation to the protocol10 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026