Delirium Clinical Trial
— DELIREAOfficial title:
Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units
Verified date | November 2020 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 379 |
Est. completion date | November 2020 |
Est. primary completion date | April 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | 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 | Oncologic Hospital | Toulouse | |
France | Rangueil Hospital | Toulouse | |
France | University Hospital Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Aïssaoui 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):1470-6. — View 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. Review. — View 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. — View Citation
Chanques G, Payen JF, Mercier G, de Lattre S, Viel E, Jung B, Cissé 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. — View 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. Review. — View 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. — View 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. — View Citation
Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3:S3. doi: 10.1186/cc6149. Epub 2008 May 14. Review. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence rate of delirium | CAM-ICU Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale. | Day 60 | |
Secondary | Duration of the delirium between the diagnosis and the resolution of the delirium | The duration of the delirium (in days) between the diagnosis and the resolution of the delirium will be done until 60 days of the stay of the patients in intensive care. | Day 60 | |
Secondary | Evaluation of cognitive and psycho-behavioral functions. | Cognitive and psycho-behavioral functions are usually evaluated by a corpus of test : memory : Test of 5 words and Free Recall Test executive : Fast Evaluation Battery for Executive Functions, Trail Making Test, Digit Span, Stroop and Verbal Fluences and Animals praxis : Mahieux's Test language : D0 80 behavior : Montgomery's scale (depression), Starkstein's scale (apathy). |
Day 60 and month 3 | |
Secondary | Quality of life at one year | The evaluation of 142 first patients delirium positive: the first 12 patients delirium positive in the 6 centers of the arm to which Toulouse will not belong, and the first 14 patients delirium positive in the 5 centers of the arm to which Toulouse will belong (Toulouse excluded), 1 year after the date of their inclusion in the study during their hospitalization in reanimation service. This evaluation of Quality of life of the first patients detected positive to delirium will be carried out using the validated French standardized questionnaire or Short Form 36 item (SF-36) which will be sent by post to the patient's home. |
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