Agitation Follow up After Introduction of a New Patient Care Algorithm (SARA)

February 5, 2022 updated by: University Hospital, Grenoble
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Actual)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • Grenoble University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted in the intensive care unit requiring and presenting a first episode of agitation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Population "before"
Patient included before implementation of care algorithm.
Population "after"
Patients included after the implementation of care algorithm and training of health professionnals
Other: Implementation of agitation care algorithm
Following the agitation care algorithm care professional adapt their behavior regarding agitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
at the end of each phase, average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Fondation Apicil

Investigators

  • Principal Investigator: Claire Chapuis, Dr, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2018

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 12, 2019

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 5, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.344
  • 2018-A00582-53 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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