Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units
NCT ID: NCT03125252
Last Updated: 2020-11-12
Study Results
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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COMPLETED
NA
379 participants
INTERVENTIONAL
2016-10-27
2020-11-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Bundle
Specific action plan : ABCDE, complemented with care related to the nursing and paramedical role concerning the patient's environmental factors
Bundle
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
Control
Standard paramedical and medical practices
Standard Paramedical and Medical practices
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
Interventions
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Bundle
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
Standard Paramedical and Medical practices
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Fanny CROZES, nurse
Role: STUDY_DIRECTOR
University Hospital, Toulouse
Locations
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Saint-André Hospital
Bordeaux, , France
Hospital Castres-Mazamet
Castres, , France
Estaing Hospital
Clermont-Ferrand, , France
Gabriel Montpied
Clermont-Ferrand, , France
Nord Hospital
Marseille, , France
Saint-Joseph Hospital
Marseille, , France
Montauban Hospital
Montauban, , France
Hospital
Montpellier, , France
Caremeau Hospital
Nîmes, , France
Perpignan Hospital
Perpignan, , France
Jacques Puel Hospital
Rodez, , France
University Hospital Toulouse
Toulouse, , France
Oncologic Hospital
Toulouse, , France
Rangueil Hospital
Toulouse, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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15 7842 16
Identifier Type: -
Identifier Source: org_study_id