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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Each patient may receive a maximum dosage of 900mg of Loxapine per day (drinkable solution through gastric probe) or the same volume of placebo. 2 initial administrations of 150 mg followed by potential readministration of 100 mg of loxapine. Maximum duration of treatment will be 14 days.The dosage by day is defined by patients' clinical condition, assessed with RASS score.
Placebo
Hôpital Louis Mourier
Colombes, France
Weaning period
Weaning period (days) between inclusion (ie first administration of loxapine/placebo) and successful extubation (no re-intubation in the following 48 hours)
Time frame: up to 28 days
total duration of mechanical ventilation
-number of days of mechanical ventilation
Time frame: up to 28 days
incidence of unexpected extubations
number of patients with unexpected extubation
Time frame: up to 28 days
clinical and biological respiratory parameters
description of abnormal clinical and biological respiratory parameters, number of patients concerned.
Time frame: 24 hours
incidence of mechanical ventilation related complications
collapses, nosocomial pneumonia, respiratory issue requiring an increase of FiO2 and/or PEP.
Time frame: up to 48 hours after extubation
incidence of adverse events, related and non related to the treatment
Time frame: up to 28 days
mortality rate
mortality rate at day 14 and week 6
Time frame: day 14 and week 6
factors associated to weaning failure
age, patient medical history,duration of sedation or ventilation, weaning failure
Time frame: up to 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.