Skip to main content
Clinical Trials/NCT04053426
NCT04053426
Completed
Not Applicable

Agitation Follow up After Introduction of a New Patient Care Algorithm

University Hospital, Grenoble1 site in 1 country138 target enrollmentJuly 19, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Agitation,Psychomotor
Sponsor
University Hospital, Grenoble
Enrollment
138
Locations
1
Primary Endpoint
RASS scale evaluation between phase "before" and phase "after"
Status
Completed
Last Updated
last year

Overview

Brief Summary

Agitation in the intensive care unit is motor hyperactivity. It is frequent (b/w 30% to 70%) and has multiple causes: pain, medical reason, delirium, medication, etc. It can be a source of complication, for the patient, and equipment pullout. International recommendations state that the agitation should be taken care of with standardized protocols to improve patient care.

Detailed Description

Data regarding patient characteristics and evaluation criterion will be collected automatically with the unit software (CCC, General Electrics) in specific file. Care and health teams enter the data systematically following the usual protocol. First Step : Follow-up and collection of data of patients included. Agitation evaluation with RASS scale, pain evaluation with BPS or NPRS. Second Step: Team training to delirium evaluation scale (CAM-ICU) and to the use of care algorithm. Third Step: Follow-up and collection of data of patients included. Use of care algorithm by doctors, nurses and back up training nurse to ensure daily information to health professionals of the care unit. Concomitant Step: Post discharge from care unit medical appointment to evaluate anxiety symptoms (HAD scale) and quality of life (SF-12)

Registry
clinicaltrials.gov
Start Date
July 19, 2018
End Date
March 31, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient presenting an agitation episode (RASS\>1)
  • Intensive care unit hospitalization
  • Patient or next of kin if patient not able non opposed on participating to the study

Exclusion Criteria

  • Decision to limit life-sustaining therapy
  • Brain damage
  • Moribund patient
  • Patient participating to another trial excluding observational studies
  • The patient is pregnant or a lactating female
  • Patient under tutorship or curatorship and liberty deprived

Outcomes

Primary Outcomes

RASS scale evaluation between phase "before" and phase "after"

Time Frame: at the end of each phase, average of 1 year

Comparison of the duration of agitation between phase "before" and phase "after"

Study Sites (1)

Loading locations...

Similar Trials