Back to resultsEvaluation of a New Mechanical Ventilation Weaning Strategy for Patients With Altered Level of Consciousness (ORGAR)
Primary Purpose
Artificial Respiration, Consciousness Disorders, Wearing Off Effect
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
mechanical ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Artificial Respiration focused on measuring Altered level of consciousness, Tracheal tube withdrawal, Respiration, Artificial Respiration, Physiology
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
Sites / Locations
- Anesthesia and CCM; Lariboisière Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Tracheal tube withdrawal governs by respiratory behaviour status
Outcomes
Primary Outcome Measures
Rate of successful mechanical ventilation weaning at 72 hours
Secondary Outcome Measures
Post tracheal tube withdrawal pneumonia at 72 hours
Rate of auto-extubation during patient's participation to the protocol
Full Information
NCT ID
NCT00700869
First Posted
June 18, 2008
Last Updated
October 4, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00700869
Brief Title
Evaluation of a New Mechanical Ventilation Weaning Strategy for Patients With Altered Level of Consciousness
Acronym
ORGAR
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
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Artificial Respiration, Consciousness Disorders, Wearing Off Effect
Keywords
Altered level of consciousness, Tracheal tube withdrawal, Respiration, Artificial Respiration, Physiology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Tracheal tube withdrawal governs by respiratory behaviour status
Intervention Type
Procedure
Intervention Name(s)
mechanical ventilation
Intervention Description
mechanical ventilation
Primary Outcome Measure Information:
Title
Rate of successful mechanical ventilation weaning at 72 hours
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Post tracheal tube withdrawal pneumonia at 72 hours
Time Frame
72 hours
Title
Rate of auto-extubation during patient's participation to the protocol
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent HEYER, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesia and CCM; Lariboisière Hospital
City
Paris
ZIP/Postal Code
75010
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a New Mechanical Ventilation Weaning Strategy for Patients With Altered Level of Consciousness
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