Agitation Follow up After Introduction of a New Patient Care Algorithm

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04053426

Acronym

SARA

Enrollment

138

Registered

2019-08-12

Start date

2018-07-19

Completion date

2021-03-31

Last updated

2024-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation,Psychomotor

Keywords

RASS, CAM-ICU

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)

Interventions

OTHERImplementation of agitation care algorithm

Following the agitation care algorithm care professional adapt their behavior regarding agitation

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
RASS scale evaluation between phase before and phase after	at the end of each phase, average of 1 year	Comparison of the duration of agitation between phase before and phase after

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026