Early Neurocognitive Rehabilitation in Intensive Care

Not Applicable

Completed

• Conditions: Critical Illness

• Registration Number: NCT02078206
• Lead Sponsor: Corporacion Parc Tauli

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-28
• Study First Submitted QC: 2014-03-03
• Study First Posted: 2014-03-05
• Study Start: 2015-11
• Primary Completion: 2020-07
• Study Completion: 2020-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Attention	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	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	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	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)
Speed processing	Hospital discharge and 3-months after hospital discharge	- Information processing speed: Symbol Search subtest of the WAIS III (Wechsler, 1999)
Functional Status	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)

Secondary Outcome Measures

Name	Time	Method
Delirium	Every day during ICU stay	Number of episodes and duration of delirium: Confusional Assessment Method for Intensive Care Unit (CAM-ICU)

Trial Locations

Locations (1)

Corporació Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain