Agitation Follow up After Introduction of a New Patient Care Algorithm

NCT04053426 | Completed

• 2 other identifiers: 38RC17.3442018-A00582-53
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Agitation,Psychomotor

Keywords

RASS; CAM-ICU

Outcome Measures

Primary Outcomes (1)

• RASS scale evaluation between phase "before" and phase "after"

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

  at the end of each phase, average of 1 year

Study Arms (2)

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

Implementation of agitation care algorithm OTHER

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

Population "after"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Fondation Apicil: collaborator

Study Sites (1)

Grenoble University Hospital

Grenoble, 38000, France

Location

Related Publications (9)

• 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.

  PMID: 16625136 BACKGROUND

• 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.

  PMID: 28099638 BACKGROUND

• 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.

  PMID: 16236951 BACKGROUND

• 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.

  PMID: 24476433 BACKGROUND

• 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.

  PMID: 23269131 BACKGROUND

• 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.

  PMID: 12799407 BACKGROUND

• 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.

  PMID: 19934877 BACKGROUND

• 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.

  PMID: 17413906 BACKGROUND

• 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.

  PMID: 14707567 BACKGROUND

MeSH Terms

Conditions

Psychomotor Agitation

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Claire Chapuis, Dr

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: August 12, 2019
• Study Start: July 19, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)