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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00700869
Other study ID # P070204
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received June 18, 2008
Last updated October 4, 2011
Start date April 2008
Est. completion date September 2011

Study information

Verified date September 2011
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
mechanical ventilation
mechanical ventilation

Locations

Country Name City State
France Anesthesia and CCM; Lariboisière Hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of successful mechanical ventilation weaning at 72 hours 72 hours Yes
Secondary Post tracheal tube withdrawal pneumonia at 72 hours 72 hours Yes
Secondary Rate of auto-extubation during patient's participation to the protocol 10 days Yes
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