An interventional study of Bundle and Standard Paramedical and Medical practices in Delirium, sponsored by University Hospital, Toulouse. Completed at 14 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-12.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Prevention
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.
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 379 is above the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Specific action plan : ABCDE, complemented with care related to the nursing and paramedical role concerning the patient's environmental factors
Other: Bundle
Standard paramedical and medical practices
Other: Standard Paramedical and Medical practices
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
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
Incidence rate of delirium
CAM-ICU Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.
Time frame: Day 60
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.
Time frame: Day 60
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).
Time frame: Day 60 and month 3
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.
Time frame: Year 1
Plan to share: No
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse