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Clinical Trials/NCT02078206
NCT02078206
Completed
Not Applicable

Early Neurocognitive Rehabilitation in Intensive Care

Corporacion Parc Tauli1 site in 1 country72 target enrollmentNovember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Corporacion Parc Tauli
Enrollment
72
Locations
1
Primary Endpoint
Speed processing
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
September 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Corporacion Parc Tauli
Responsible Party
Principal Investigator
Principal Investigator

Lluis Blanch

PhD

Corporacion Parc Tauli

Eligibility Criteria

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

Speed processing

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

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

Functional Status

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

* 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)

Attention

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

* 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)

Psychopathological status

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

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

Memory

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

* 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)

Executive Functions

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

* 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)

Secondary Outcomes

  • Delirium(Every day during ICU stay)

Study Sites (1)

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