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
  Purpose

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.


Condition Intervention Phase
Artificial Respiration
Consciousness Disorders
Wearing Off Effect
Procedure: mechanical ventilation
Phase 2
Phase 3

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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Rate of successful mechanical ventilation weaning at 72 hours [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 34
Study Start Date: April 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Tracheal tube withdrawal governs by respiratory behaviour status
Procedure: mechanical ventilation
mechanical ventilation
Other Name: mechanical ventilation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700869

Locations
France
Anesthesia and CCM; Lariboisière Hospital
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Laurent HEYER, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00700869     History of Changes
Other Study ID Numbers: P070204
Study First Received: June 18, 2008
Last Updated: October 4, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Altered level of consciousness
Tracheal tube withdrawal
Respiration
Artificial Respiration
Physiology

Additional relevant MeSH terms:
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014