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Loxapine and Weaning From Ventilator

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ClinicalTrials.gov Identifier: NCT00122733
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : July 23, 2007
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Psychomotor Agitation Drug: loxapine Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Facilitation of Weaning From Ventilator by Loxapine
Study Start Date : December 2005
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. cessation of agitation [ Time Frame: 3 hours ]
  2. improvement in the clinical and biological parameters of weaning trial [ Time Frame: 3 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are eligible for weaning from the respirator (FIO2 less than 50%; positive end expiratory pressure [PEEP] level less than 6 cmH2O)
  • Patients whose agitation (according to accepted scores) during a weaning trial precludes extubation

Exclusion Criteria:

  • History of convulsions or epilepsy
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122733


Locations
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France
Service de Réanimation, Hopital Louis Mourier
Colombes, France, 92700
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Guillaume CHEVREL, MD Assistance Publique - Hôpitaux de Paris
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00122733    
Other Study ID Numbers: LMR2
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: July 23, 2007
Last Verified: July 2007
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Mechanical ventilation
Agitation
Difficult weaning
Additional relevant MeSH terms:
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Respiratory Insufficiency
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Respiration Disorders
Respiratory Tract Diseases
Loxapine
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action