Skip to main content
OpenTrials
Completed

NCT Number: NCT00700869

Evaluation of a New Mechanical Ventilation Weaning Strategy 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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mechanical ventilation

Procedure

mechanical ventilation

Primary outcomes

  1. Rate of successful mechanical ventilation weaning at 72 hours

    Time frame: 72 hours

Secondary outcomes

  1. Post tracheal tube withdrawal pneumonia at 72 hours

    Time frame: 72 hours

  2. Rate of auto-extubation during patient's participation to the protocol

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: ORGAR

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 19, 2008
Registry last updated
Oct 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.