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OpenTrials
Completed

NCT Number: NCT04053426

Agitation Follow up After Introduction of a New Patient Care Algorithm

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.

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implementation of agitation care algorithm

Other

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

Primary outcomes

  1. 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"

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Fondation Apicil

Registry information

Acronym: SARA

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2019
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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