Respiratory Insufficiency Clinical Trial
Official title:
Facilitation of Weaning From Ventilator by Loxapine
Patients may be very agitated during the weaning period from mechanical ventilation. Administration of loxapine, a neuroleptic that does not notably affect ventilatory drive, may help in obtaining an adequate level of cooperation and, therefore, in reducing the duration of mechanical ventilation.
Mechanical ventilation is a life-saving procedure in critically ill patients. This procedure
is however not devoid of risks and every effort should be made to shorten its duration. This
is best accomplished by the implementation of weaning protocols. Sedation (by opiates and
benzodiazepines) is often required in such patients for their comfort and adaptation to the
respirator. Withdrawal of sedation in order to allow patients to resume spontaneous
breathing may be associated with agitation and confusion that may hinder weaning. In such
cases, reinstitution of heavy sedation will prolong ventilator-dependency. It may therefore
be interesting to administer a neuroleptic (loxapine) with good anxiolytic properties but
that does not notably interfere with spontaneous breathing ability.
Patients will be included when they fail a spontaneous ventilation trial (see inclusion
criteria) because of marked agitation. Usual simple clinical (respiratory frequency, P01
measured on the respirator, arterial pressure, cardiac rate) and biological criteria
(arterial blood gas determination) and a measurement of sedation/agitation with validated
scales (Richmond agitation sedation scale, Ramsay score) will be gathered when a patient is
deemed ready for a trial of spontaneous ventilation for weaning. In cases of marked
agitation according to validated scales, patients will be given a conventional dose (150 mg)
of loxapine by the nasogastric tube and the efficacy of this treatment will be evaluated on
the same parameters as above. Demonstration of the facilitation of weaning by this simple
strategy would be useful in order to reduce risks associated with mechanical ventilation.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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