NCT00122733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 23, 2007

Status Verified

July 1, 2007

First QC Date

July 19, 2005

Last Update Submit

July 20, 2007

Conditions

Respiratory InsufficiencyPsychomotor Agitation

Keywords

Mechanical ventilationAgitationDifficult weaning

Outcome Measures

Primary Outcomes (2)

  • cessation of agitation

    3 hours

  • improvement in the clinical and biological parameters of weaning trial

    3 hours

Interventions

loxapineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of convulsions or epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Réanimation, Hopital Louis Mourier

Colombes, 92700, France

Location

Related Publications (2)

  • 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. doi: 10.1001/jama.289.22.2983.

    PMID: 12799407BACKGROUND

  • 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. No abstract available.

    PMID: 12725193BACKGROUND

MeSH Terms

Conditions

Respiratory InsufficiencyPsychomotor Agitation

Interventions

Loxapine

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesDyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

DibenzoxazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Guillaume CHEVREL, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2005

First Posted

July 22, 2005

Study Start

December 1, 2005

Study Completion

December 1, 2006

Last Updated

July 23, 2007

Record last verified: 2007-07

Locations

FR(1)