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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00700869
First received: June 18, 2008
Last updated: October 4, 2011
Last verified: September 2011

June 18, 2008
October 4, 2011
April 2008
September 2011   (final data collection date for primary outcome measure)
Rate of successful mechanical ventilation weaning at 72 hours [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00700869 on ClinicalTrials.gov Archive Site
  • Post tracheal tube withdrawal pneumonia at 72 hours [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
  • Rate of auto-extubation during patient's participation to the protocol [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Artificial Respiration
  • Consciousness Disorders
  • Wearing Off Effect
Procedure: mechanical ventilation
mechanical ventilation
Other Name: mechanical ventilation
Experimental: 1
Tracheal tube withdrawal governs by respiratory behaviour status
Intervention: Procedure: mechanical ventilation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00700869
P070204
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Laurent HEYER, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP