Loxapine and Weaning From Ventilator

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

Tracking Information

• First Submitted Date: July 19, 2005
• First Posted Date: July 22, 2005
• Last Update Posted Date: July 23, 2007
• Study Start Date: December 2005
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: July 20, 2007)

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

Original Primary Outcome Measures (submitted: July 19, 2005)

• cessation of agitation
• improvement in the clinical and biological parameters of weaning trial

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Loxapine and Weaning From Ventilator
• Official Title: Facilitation of Weaning From Ventilator by Loxapine
• 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Respiratory Insufficiency
• Psychomotor Agitation

• Intervention: Drug: loxapine
• Study Arms: Not Provided

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. Erratum in: Crit Care Nurse. 2003 Jun;23(3):14.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 20, 2007): 9
• Original Enrollment (submitted: July 19, 2005): 20
• Actual Study Completion Date: December 2006
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00122733
• Other Study ID Numbers: LMR2
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Not Provided

Investigators

• Principal Investigator: Guillaume CHEVREL, MD; Assistance Publique - Hôpitaux de Paris

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: July 2007