Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units

NCT03125252 | Completed

• 1 other identifier: 15 7842 16
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 14

Brief Summary

The main objective is to evaluate the impact of the "bundle of actions" on the delirium's incidence in resuscitation patients during their stay in the service, compared to a conventional treatment. The investigators therefore hypothesize that a set of coordinated paramedical actions in the prevention of delirium would reduce its incidence by 15% compared to conventional care.

Conditions

Delirium

Keywords

Delirium; Reanimation; Conversational hypnosis

Outcome Measures

Primary Outcomes (1)

• Incidence rate of delirium

  CAM-ICU Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.

  Day 60

Secondary Outcomes (3)

• Duration of the delirium between the diagnosis and the resolution of the delirium

  Day 60

• Evaluation of cognitive and psycho-behavioral functions.

  Day 60 and month 3

• Quality of life at one year

  Year 1

Study Arms (2)

Bundle

EXPERIMENTAL

Specific action plan : ABCDE, complemented with care related to the nursing and paramedical role concerning the patient's environmental factors

Other: Bundle

Control

OTHER

Standard paramedical and medical practices

Other: Standard Paramedical and Medical practices

Interventions

Bundle OTHER

Awakening and Breathing Coordination Delirium monitoring and management (detection and management of delirium) Early mobility Factors of environment: * thirst * noise * pain and well-being * sleep * isolation

Also known as: ABCDE

Bundle

Standard Paramedical and Medical practices OTHER

The current recommendations recommend the following scheme: * Identification and correction of an organic cause / factors (sepsis, metabolic disorders, withdrawal syndrome, pain) * Use of non-pharmacological means (early mobilization, correction of sensory deficits, temporo-spatial reorientation strategies) * Use of reference antipsychotic pharmacological means

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent signed by the trusted person and the patient upon waking
• Hospitalized in reanimation service (first hospitalization or transfer of another service)
• hours of sedation with intubation during hospitalization (all combinations of morphine, hypnotics, sedatives, anesthetics, narcoleptics)
• Francophone (able to understand all evaluations)
• Absence of pre-existing cognitive impairment (patients whose relative has completed the IQCode questionnaire and whose score is \<3.4 points)
• Visual, auditory (authorized equipment) skills and adequate oral or written expression for the proper conduct of neuropsychological tests.

You may not qualify if:

• Pregnant women
• Evolutive neurological disease leading to cognitive impairment (multiple sclerosis, Parkinson's disease, Alzheimer's disease), and / or focal neurological disease leading to cognitive impairment (head trauma, stroke, ...)
• Evolving psychiatric illness (including severe depression)
• Voluntary drug poisoning
• Patients who have already participated in the study

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (14)

Saint-André Hospital

Bordeaux, 33000, France

Location

Hospital Castres-Mazamet

Castres, 81, France

Location

Estaing Hospital

Clermont-Ferrand, 63100, France

Location

Gabriel Montpied

Clermont-Ferrand, 63100, France

Location

Nord Hospital

Marseille, 13015, France

Location

Saint-Joseph Hospital

Marseille, 13285, France

Location

Montauban Hospital

Montauban, 82000, France

Location

Hospital

Montpellier, 34090, France

Location

Caremeau Hospital

Nîmes, 30929, France

Location

Perpignan Hospital

Perpignan, 66046, France

Location

Jacques Puel Hospital

Rodez, 12027, France

Location

University Hospital Toulouse

Toulouse, 31000, France

Location

Oncologic Hospital

Toulouse, 31059, France

Location

Rangueil Hospital

Toulouse, 31059, France

Location

Related Publications (10)

• Aissaoui Y, Zeggwagh AA, Zekraoui A, Abidi K, Abouqal R. Validation of a behavioral pain scale in critically ill, sedated, and mechanically ventilated patients. Anesth Analg. 2005 Nov;101(5):1470-1476. doi: 10.1213/01.ANE.0000182331.68722.FF.

  PMID: 16244013 BACKGROUND

• Arend E, Christensen M. Delirium in the intensive care unit: a review. Nurs Crit Care. 2009 May-Jun;14(3):145-54. doi: 10.1111/j.1478-5153.2008.00324.x.

  PMID: 19366412 BACKGROUND

• Balas MC, Vasilevskis EE, Burke WJ, Boehm L, Pun BT, Olsen KM, Peitz GJ, Ely EW. Critical care nurses' role in implementing the "ABCDE bundle" into practice. Crit Care Nurse. 2012 Apr;32(2):35-8, 40-7; quiz 48. doi: 10.4037/ccn2012229.

  PMID: 22467611 BACKGROUND

• Chanques G, Payen JF, Mercier G, de Lattre S, Viel E, Jung B, Cisse M, Lefrant JY, Jaber S. Assessing pain in non-intubated critically ill patients unable to self report: an adaptation of the Behavioral Pain Scale. Intensive Care Med. 2009 Dec;35(12):2060-7. doi: 10.1007/s00134-009-1590-5.

  PMID: 19697008 BACKGROUND

• Devlin JW, Brummel NE, Al-Qadheeb NS. Optimising the recognition of delirium in the intensive care unit. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):385-93. doi: 10.1016/j.bpa.2012.08.002.

  PMID: 23040288 BACKGROUND

• Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.

  PMID: 15082703 BACKGROUND

• Erickson MH, Rossi EL. Two level communication and the microdynamics of trance and suggestion. Am J Clin Hypn. 1976 Jan;18(3):153-71. doi: 10.1080/00029157.1976.10403794. No abstract available.

  PMID: 1246970 BACKGROUND

• Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14.

  PMID: 18495054 BACKGROUND

• Guenther U, Popp J, Koecher L, Muders T, Wrigge H, Ely EW, Putensen C. Validity and reliability of the CAM-ICU Flowsheet to diagnose delirium in surgical ICU patients. J Crit Care. 2010 Mar;25(1):144-51. doi: 10.1016/j.jcrc.2009.08.005. Epub 2009 Oct 13.

  PMID: 19828283 BACKGROUND

• McCusker J, Cole MG, Voyer P, Monette J, Champoux N, Ciampi A, Vu M, Belzile E. Six-month outcomes of co-occurring delirium, depression, and dementia in long-term care. J Am Geriatr Soc. 2014 Dec;62(12):2296-302. doi: 10.1111/jgs.13159. Epub 2014 Dec 8.

  PMID: 25482152 BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Fanny CROZES, nurse

  University Hospital, Toulouse

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: April 24, 2017
• Study Start: October 27, 2016
• Primary Completion: April 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)