Early Neurocognitive Rehabilitation in Intensive Care

Critical Illness Clinical Trial

— ENRIC  

Official title:

Early Neurocognitive Rehabilitation in Intensive Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078206
• Other study ID #: FPT-2013/057
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: September 2020

Study information

• Verified date: March 2022
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• Neurocognitive stimulation

Locations

Country	Name	City	State
Spain	Corporació Parc Taulí	Sabadell	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Fundació La Marató de TV3

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Hospital discharge and 3-months after hospital discharge
Primary	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)	Hospital discharge and 3-months after hospital disharge
Primary	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)	Hospital discharge and 3-months after hospital discharge
Primary	Speed processing	- Information processing speed: Symbol Search subtest of the WAIS III (Wechsler, 1999)	Hospital discharge and 3-months after hospital discharge
Primary	Psychopathological status	Depression: Hamilton Depression Rating Scale (HDRS) (Hamilton, 1960); Anxiety: Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959)	Hospital discharge and 3-monts after hospital discharge
Primary	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)	hospital discharge and 3-months after hospital discharge
Secondary	Delirium	Number of episodes and duration of delirium: Confusional Assessment Method for Intensive Care Unit (CAM-ICU)	Every day during ICU stay