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

Delirium Clinical Trial

— DELIREA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125252
• Other study ID #: 15 7842 16
• Status: Completed
• Phase: N/A
• Start date: October 27, 2016
• Est. completion date: November 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Delirium

Intervention

Other:
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (10)

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

Outcome

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.	Year 1