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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 March 2022 |
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Main ID: |
NCT02078206 |
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Date of registration:
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28/02/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Early Neurocognitive Rehabilitation in Intensive Care
ENRIC |
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Scientific title:
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Early Neurocognitive Rehabilitation in Intensive Care |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02078206 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Lluis Blanch, Phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fundació Parc Taulí |
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Name:
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Antoni Artigas, Phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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Corporació Parc Taulí- Critical Care Unit chair |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients aged between 18 and 80 years
- Patients receiving mechanical ventilation for at least 24 hours
- Patients scoring more than 8 on the Glasgow Coma Scale (GCS) and more than 2 on the
Sedation Agitation Scale (SAS)
- Patients haemodynamically stable
- Informed consent signed by the closest relatives.
Exclusion Criteria:
- Patients with previous neurologic pathology or focal brain injury before ICU admission
- Patients with serious psychiatric pathology (major depression, psychosis, bipolar
disease) or mentally retarded
- Patients with sensorial alterations needed to interact with the neurocognitive
stimulation programme
- patients whose closest relatives refuse the subject to be included in the study.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Critical Illness
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Intervention(s)
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Other: Neurocognitive stimulation
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Primary Outcome(s)
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Psychopathological status
[Time Frame: Hospital discharge and 3-monts after hospital discharge]
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Executive Functions
[Time Frame: Hospital discharge and 3-months after hospital discharge]
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Speed processing
[Time Frame: Hospital discharge and 3-months after hospital discharge]
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Attention
[Time Frame: Hospital discharge and 3-months after hospital discharge]
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Functional Status
[Time Frame: hospital discharge and 3-months after hospital discharge]
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Memory
[Time Frame: Hospital discharge and 3-months after hospital disharge]
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Secondary Outcome(s)
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Delirium
[Time Frame: Every day during ICU stay]
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Secondary ID(s)
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FPT-2013/057
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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