Loxapine and Weaning From Ventilator - Full Text View

Purpose

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	Intervention
Respiratory Insufficiency Psychomotor Agitation	Drug: loxapine

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Facilitation of Weaning From Ventilator by Loxapine

Resource links provided by NLM:

MedlinePlus related topics: Respiratory Failure

Drug Information available for: Loxapine Loxapine succinate Loxapine hydrochloride

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

cessation of agitation [ Time Frame: 3 hours ]
improvement in the clinical and biological parameters of weaning trial [ Time Frame: 3 hours ]

Enrollment:	9
Study Start Date:	December 2005
Study Completion Date:	December 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122733

Locations

France
Service de Réanimation, Hopital Louis Mourier
Colombes, France, 92700

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Guillaume CHEVREL, MD

Assistance Publique - Hôpitaux de Paris

More Information

Publications:

Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91.

Truman B, Ely EW. Monitoring delirium in critically ill patients. Using the confusion assessment method for the intensive care unit. Crit Care Nurse. 2003 Apr;23(2):25-36; quiz 37-8. Review. No abstract available. Erratum in: Crit Care Nurse. 2003 Jun;23(3):14.

ClinicalTrials.gov Identifier:	NCT00122733 History of Changes
Other Study ID Numbers:	LMR2
Study First Received:	July 19, 2005
Last Updated:	July 20, 2007
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Mechanical ventilation
Agitation
Difficult weaning

Additional relevant MeSH terms:

Respiratory Insufficiency
Psychomotor Agitation
Respiration Disorders
Respiratory Tract Diseases
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Loxapine
Antipsychotic Agents

Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 13, 2013