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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03125252
Acronym
DELIREA
Enrollment
379
Registered
2017-04-24
Start date
2016-10-27
Completion date
2020-11-30
Last updated
2020-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

Delirium, Reanimation, Conversational hypnosis

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.

Interventions

OTHERBundle

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

OTHERStandard 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

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence rate of deliriumDay 60CAM-ICU Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.

Secondary

MeasureTime frameDescription
Duration of the delirium between the diagnosis and the resolution of the deliriumDay 60The 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.
Evaluation of cognitive and psycho-behavioral functions.Day 60 and month 3Cognitive 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).
Quality of life at one yearYear 1The 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026