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

T

Toulouse University Hospital

Status

Completed

Conditions

Delirium

Treatments

Other: Bundle
Other: Standard Paramedical and Medical practices

Study type

Interventional

Funder types

Other

Identifiers

NCT03125252
15 7842 16

Details and patient eligibility

About

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.

Full 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.

Enrollment

379 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

379 participants in 2 patient groups

Bundle
Experimental group
Description:
Specific action plan : ABCDE, complemented with care related to the nursing and paramedical role concerning the patient's environmental factors
Treatment:
Other: Bundle
Control
Other group
Description:
Standard paramedical and medical practices
Treatment:
Other: Standard Paramedical and Medical practices

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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