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NCT Number: NCT03125252

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

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.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint-André Hospital, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bundle

Other

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

Other names: ABCDE

Standard Paramedical and Medical practices

Other

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

Primary outcomes

  1. Incidence rate of delirium

    Time frame: Day 60

    CAM-ICU Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.

Secondary outcomes

  1. Duration of the delirium between the diagnosis and the resolution of the delirium

    Time frame: Day 60

    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.

  2. Evaluation of cognitive and psycho-behavioral functions.

    Time frame: Day 60 and month 3

    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).

  3. Quality of life at one year

    Time frame: Year 1

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: DELIREA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2017
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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