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Trial record 1 of 1 for:    Recruiting, Not yet recruiting Studies | Delirium | Toulouse, France
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Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units (DELIREA)

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ClinicalTrials.gov Identifier: NCT03125252
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease Intervention/treatment Phase
Delirium Other: Bundle Other: Standard Paramedical and Medical practices Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 952 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units
Actual Study Start Date : October 27, 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Bundle
Specific action plan : ABCDE, complemented with care related to the nursing and paramedical role concerning the patient's environmental factors
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
Other Name: ABCDE

Control
Standard paramedical and medical practices
Other: 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




Primary Outcome Measures :
  1. Incidence rate of delirium [ Time Frame: Day 60 ]
    CAM-ICU Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.


Secondary Outcome Measures :
  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.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125252


Contacts
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Contact: Stein Silva, MD 5 61 77 77 94 ext 33 silva.s@chu-toulouse.fr
Contact: Fanny Crozes, nurse 5 61 77 57 81 ext 33 crozes.f@chu-toulouse.fr

Locations
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France
Saint-André Hospital Recruiting
Bordeaux, France, 33000
Principal Investigator: Gaelle MOURISSOUX, MD         
Sub-Investigator: Solange LESCLAUZE, Nurse         
Hospital Castres-Mazamet Recruiting
Castres, France, 81
Principal Investigator: Marie-Odile LAFFORGUE, MD         
Sub-Investigator: Isabelle ARMENGAUD, Nurse         
Estaing Hospital Recruiting
Clermont-Ferrand, France, 63100
Principal Investigator: Jean-Michel CONSTANTIN, MD         
Sub-Investigator: Laetitia STURMA, Nurse         
Gabriel Montpied Recruiting
Clermont-Ferrand, France, 63100
Principal Investigator: Bertrand SOUWEINE, MD         
Sub-Investigator: Mathilde CHAMBON, Nurse         
Nord Hospital Recruiting
Marseille, France, 13015
Principal Investigator: Marc LEONE, MD         
Sub-Investigator: Frederic IRIDE, Nurse         
Saint-Joseph Hospital Recruiting
Marseille, France, 13285
Principal Investigator: Patrice ANTOLINI, MD         
Sub-Investigator: Marie RAFFRAY, Nurse         
Montauban Hospital Recruiting
Montauban, France, 82000
Principal Investigator: Frédéric BELLEC, MD         
Hospital Recruiting
Montpellier, France, 34090
Principal Investigator: Samir JABER, MD         
Sub-Investigator: Jeanne BOYER, Nurse         
Caremeau Hospital Recruiting
Nîmes, France, 30929
Principal Investigator: Laurent MULLER, MD         
Sub-Investigator: Sophie LLORET, Nurse         
Perpignan Hospital Recruiting
Perpignan, France, 66046
Contact: Jean-Antoine TRILLE         
Principal Investigator: Jean-Antoine TRILLE, MD         
Jacques Puel Hospital Recruiting
Rodez, France, 12027
Principal Investigator: Christine BRASSE, MD         
Sub-Investigator: Caroline DUPONT-MALRIC, Nurse         
University Hospital Toulouse Recruiting
Toulouse, France, 31000
Contact: Stein SILVA, MD       silva.s@chu-toulouse.fr   
Contact: Fanny CROZES, Study nurse       crozes.f@chu-toulouse.fr   
Oncologic Hospital Recruiting
Toulouse, France, 31059
Principal Investigator: Guillaume DUCOS, MD         
Sub-Investigator: Séverine SEAILLES, Nurse         
Rangueil Hospital Recruiting
Toulouse, France, 31059
Principal Investigator: Thierry SEGUIN, MD         
Sub-Investigator: Sophie COMET, Nurse         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Study Director: Fanny CROZES, nurse University Hospital, Toulouse

Publications:

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03125252    
Other Study ID Numbers: 15 7842 16
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Delirium
Reanimation
Conversational hypnosis
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders