Clinical trial NCT03125252: Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units
Official title: Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Keywords: Delirium
Reanimation
Conversational hypnosis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The "Bundle of Actions" is a coordinated and specific action plan, which has already been validated, focusing on the coordination of wake-up and respiration, the management of delirium, as well as the early mobility of the patient. Innovation consists of simple, reproducible nursing care that reduces triggers of delirium; as well as the use of two new approaches in reanimation: conversational hypnosis and early and comprehensive re-empowerment of the patient in the management of his pain and well-being.

Eligibility criteria: Inclusion Criteria:

* Informed consent signed by the trusted person and the patient upon waking
* Hospitalized in reanimation service (first hospitalization or transfer of another service)
* 48 hours of sedation with intubation during hospitalization (all combinations of morphine, hypnotics, sedatives, anesthetics, narcoleptics)
* Francophone (able to understand all evaluations)

Criteria for the inclusion of 50 delirium positive patients drawn from the Toulouse center (participating in the neuropsychological evaluation): In addition to those mentioned above:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence rate of delirium
timeFrame: Day 60
Secondary outcomes:
measure: Duration of the delirium between the diagnosis and the resolution of the delirium
timeFrame: Day 60
measure: Evaluation of cognitive and psycho-behavioral functions.
timeFrame: Day 60 and month 3
measure: Quality of life at one year
timeFrame: Year 1
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Saint-André Hospital
city: Castres
country: France
facility: Hospital Castres-Mazamet
city: Clermont-Ferrand
country: France
facility: Estaing Hospital
city: Clermont-Ferrand
country: France
facility: Gabriel Montpied
city: Marseille
country: France
facility: Nord Hospital
city: Marseille
country: France
facility: Saint-Joseph Hospital
city: Montauban
country: France
facility: Montauban Hospital
city: Montpellier
country: France
facility: Hospital
city: Nîmes
country: France
facility: Caremeau Hospital
city: Perpignan
country: France
facility: Perpignan Hospital
city: Rodez
country: France
facility: Jacques Puel Hospital
city: Toulouse
country: France
facility: University Hospital Toulouse
city: Toulouse
country: France
facility: Oncologic Hospital
city: Toulouse
country: France
facility: Rangueil Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Fanny CROZES, nurse
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.