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CompletedNCT04053426SARAUpdated May 28, 2024

Agitation Follow up After Introduction of a New Patient Care Algorithm

An observational study in Agitation,Psychomotor, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-28.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
138
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Agitation,Psychomotor

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Keywords

  • RASS
  • CAM-ICU
03

In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's enrollment of 138 is below the median of 154 across 71 observational studies indexed under Psychomotor Agitation.

Browse Psychomotor Agitation studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
138 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherImplementation of agitation care algorithm

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

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What researchers measure

Primary outcomes

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

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

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

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Study locations

1 site
  • Grenoble University Hospital
    Grenoble, 38000, France
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References and documents

Publications

  • 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. PubMed 16625136 ↗
  • 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. PubMed 28099638 ↗
  • 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. PubMed 16236951 ↗
  • 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. PubMed 24476433 ↗
  • 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. PubMed 23269131 ↗
  • 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. PubMed 12799407 ↗
  • 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. PubMed 19934877 ↗
  • 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. PubMed 17413906 ↗
  • 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. PubMed 14707567 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04053426
Lead sponsor
University Hospital, Grenoble
Collaborators
Fondation Apicil
Responsible party
Sponsor
First posted
Aug 12, 2019
Start date
Jul 19, 2018
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021
Last update
May 28, 2024

Study contacts

Claire Chapuis, Dr
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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