Clinical Trial: Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Assessment of Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning

Brief Summary: This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming patients down in a situation of restlessness during mechanical ventilation weaning. This drug is used for several years to quieten restless patients. Its purpose is to restore spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical ventilation.

Detailed Summary: This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming patients down in a situation of restlessness during mechanical ventilation weaning. This drug is used for several years to quieten restless patients. Its purpose is to restore spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical ventilation. 300 patients will participate in the study and will be randomized, after informed consent, to receive either loxapine or a placebo.Patients whose proxies refuse participation will be sedated according to standard care procedures.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Weaning period [ Time Frame: up to 28 days ]

Weaning period (days) between inclusion (ie first administration of loxapine/placebo) and successful extubation (no re-intubation in the following 48 hours)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • total duration of mechanical ventilation [ Time Frame: up to 28 days ]
    -number of days of mechanical ventilation
  • incidence of unexpected extubations [ Time Frame: up to 28 days ]
    number of patients with unexpected extubation
  • clinical and biological respiratory parameters [ Time Frame: 24 hours ]
    description of abnormal clinical and biological respiratory parameters, number of patients concerned.
  • incidence of mechanical ventilation related complications [ Time Frame: up to 48 hours after extubation ]
    collapses, nosocomial pneumonia, respiratory issue requiring an increase of FiO2 and/or PEP.
  • incidence of adverse events, related and non related to the treatment [ Time Frame: up to 28 days ]
  • mortality rate [ Time Frame: day 14 and week 6 ]
    mortality rate at day 14 and week 6
  • factors associated to weaning failure [ Time Frame: up to 28 days ]
    age, patient medical history,duration of sedation or ventilation, weaning failure


Original Secondary Outcome:

  • total duration of mechanical ventilation [ Time Frame: up to 28 days ]
    -number of days of mechanical ventilation
  • incidence of unexpected extubations [ Time Frame: up to 28 days ]
    number of patients with unexpected extubation
  • clinical and biological respiratory parameters [ Time Frame: 24 hours ]
    description of abnormal clinical and biological respiratory parameters, number of patients concerned.
  • incidence of mechanical ventilation related complications [ Time Frame: up to 48 hours after extubation ]
    collapsus, nosocomial pneumonia, respiratory issue requiring an increase of FiO2 and/or PEP.
  • incidence of adverse events, related and non related to the treatment [ Time Frame: up to 28 days ]
  • mortality rate [ Time Frame: day 14 and week 6 ]
    mortality rate at day 14 and week 6
  • factors associated to weaning failure [ Time Frame: up to 28 days ]
    age, patient medical history,duration of sedation or ventilation, weaning failure


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: August 26, 2010
Date Started: May 2011
Date Completion:
Last Updated: July 17, 2014
Last Verified: July 2012