Early Neurocognitive Rehabilitation in Intensive Care

N/ACompletedNCT02078206

Corporacion Parc Tauli72 enrolled

Overview

The purpose of this project is to assess the efficacy of an early neurocognitive intervention for ICU patients, in terms of psychopathological, neuropsychological and functional improvement. The treatment is supported in an interactive advanced computing platform that includes the continuous biomedical registration of the patients and a virtual reality software specifically designed for critical patients. The investigators expect an improvement in neuropsychological, psychopathological and functional status at hospital discharge and 3 months follow-up in those patients that have received the early neurocognitive intervention comparing with patients treated as usual. Furthermore the investigators expect a decrease of episodes and/or duration of delirium in ICU patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Critical Illness

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Attention

* Verbal attention: Digits Forward subtest of the WAIS III (Wechsler, 1999) * Visual attention: Spatial Localization Forward subtest of the WMS III (Wechsler, 1999) * Sustained/Selective attention: Continuous Performance Test (Conners, 1992)

Time frame: Hospital discharge and 3-months after hospital discharge

Memory

* Verbal learning and memory: Auditory Verbal Learning Test (Rey, 1964) * Visual learning and memory: 10/36 Spatial Recall Test (Rao, 1992) * Visual recognition: Benton Visual Retention Test (Benton, 1983)

Time frame: Hospital discharge and 3-months after hospital disharge

Executive Functions

* Stimuli alternation and sequencing: Trail Making Test A-B (Mimeo \& Manga, 1999) * Automatic inhibition response: Stroop Test (Golden \& Charles, 1978) * Visual planning: Tower of London (Shallice, 1982). * Phonetic verbal fluency: FAS test (Spreen and Benton, 1995) * Semantic verbal fluency: Animals 1' (Benton \& Hamsher, 1976)

Time frame: Hospital discharge and 3-months after hospital discharge

Speed processing

\- Information processing speed: Symbol Search subtest of the WAIS III (Wechsler, 1999)

Time frame: Hospital discharge and 3-months after hospital discharge

Psychopathological status

* Depression: Hamilton Depression Rating Scale (HDRS) (Hamilton, 1960) * Anxiety: Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959)

Time frame: Hospital discharge and 3-monts after hospital discharge

Functional Status

* Quality of life questionnaire: Satisfaction and Pleasure (Q-LES-Q) (Endicott, J., Nee, J., Harrison, W. \& Blumenthal, R., 1993) * Lawton and Brody Functional Scale (1969)

Time frame: hospital discharge and 3-months after hospital discharge

Secondary Outcomes

Delirium

Number of episodes and duration of delirium: Confusional Assessment Method for Intensive Care Unit (CAM-ICU)

Time frame: Every day during ICU stay

Early Neurocognitive Rehabilitation in Intensive Care

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes