Agitation Follow up After Introduction of a New Patient Care Algorithm

NCT ID: NCT04053426

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-19

Study Completion Date

2021-03-31

Brief Summary

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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

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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)

Conditions

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Agitation,Psychomotor

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Population "before"

Patient included before implementation of care algorithm.

No interventions assigned to this group

Population "after"

Patients included after the implementation of care algorithm and training of health professionnals

Implementation of agitation care algorithm

Intervention Type OTHER

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

Interventions

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Implementation of agitation care algorithm

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Apicil

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Chapuis, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Grenoble University Hospital

Grenoble, , France

Site Status

Countries

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France

References

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Chanques G, Jaber S, Barbotte E, Violet S, Sebbane M, Perrigault PF, Mann C, Lefrant JY, Eledjam JJ. Impact of systematic evaluation of pain and agitation in an intensive care unit. Crit Care Med. 2006 Jun;34(6):1691-9. doi: 10.1097/01.CCM.0000218416.62457.56.

Reference Type BACKGROUND
PMID: 16625136 (View on PubMed)

Almeida TM, Azevedo LC, Nose PM, Freitas FG, Machado FR. Risk factors for agitation in critically ill patients. Rev Bras Ter Intensiva. 2016 Oct-Dec;28(4):413-419. doi: 10.5935/0103-507X.20160074.

Reference Type BACKGROUND
PMID: 28099638 (View on PubMed)

Jaber S, Chanques G, Altairac C, Sebbane M, Vergne C, Perrigault PF, Eledjam JJ. A prospective study of agitation in a medical-surgical ICU: incidence, risk factors, and outcomes. Chest. 2005 Oct;128(4):2749-57. doi: 10.1378/chest.128.4.2749.

Reference Type BACKGROUND
PMID: 16236951 (View on PubMed)

Reade MC, Finfer S. Sedation and delirium in the intensive care unit. N Engl J Med. 2014 Jan 30;370(5):444-54. doi: 10.1056/NEJMra1208705. No abstract available.

Reference Type BACKGROUND
PMID: 24476433 (View on PubMed)

Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.

Reference Type BACKGROUND
PMID: 23269131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12799407 (View on PubMed)

Payen JF, Bosson JL, Chanques G, Mantz J, Labarere J; DOLOREA Investigators. Pain assessment is associated with decreased duration of mechanical ventilation in the intensive care unit: a post Hoc analysis of the DOLOREA study. Anesthesiology. 2009 Dec;111(6):1308-16. doi: 10.1097/ALN.0b013e3181c0d4f0.

Reference Type BACKGROUND
PMID: 19934877 (View on PubMed)

Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology. 2007 Apr;106(4):687-95; quiz 891-2. doi: 10.1097/01.anes.0000264747.09017.da.

Reference Type BACKGROUND
PMID: 17413906 (View on PubMed)

Ely EW, Stephens RK, Jackson JC, Thomason JW, Truman B, Gordon S, Dittus RS, Bernard GR. Current opinions regarding the importance, diagnosis, and management of delirium in the intensive care unit: a survey of 912 healthcare professionals. Crit Care Med. 2004 Jan;32(1):106-12. doi: 10.1097/01.CCM.0000098033.94737.84.

Reference Type BACKGROUND
PMID: 14707567 (View on PubMed)

Other Identifiers

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2018-A00582-53

Identifier Type: OTHER

Identifier Source: secondary_id

38RC17.344

Identifier Type: -

Identifier Source: org_study_id

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