Clinical trial NCT02078206: Early Neurocognitive Rehabilitation in Intensive Care
Official title: Early Neurocognitive Rehabilitation in Intensive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Critical illness
Neurocognition
Neurocognitive stimulation
Delirium
Virtual Reality
cognitive
rehabilitation
ICU
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Fundació La Marató de TV3
First posted: 2014-03-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Attention
timeFrame: Hospital discharge and 3-months after hospital discharge
measure: Memory
timeFrame: Hospital discharge and 3-months after hospital disharge
measure: Executive Functions
timeFrame: Hospital discharge and 3-months after hospital discharge
measure: Speed processing
timeFrame: Hospital discharge and 3-months after hospital discharge
measure: Psychopathological status
timeFrame: Hospital discharge and 3-monts after hospital discharge
measure: Functional Status
timeFrame: hospital discharge and 3-months after hospital discharge
Secondary outcomes:
measure: Delirium
timeFrame: Every day during ICU stay
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporació Parc Taulí
state: Barcelona
Study officials:
affiliation: Fundació Parc Taulí
name: Lluis Blanch, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporació Parc Taulí- Critical Care Unit chair
name: Antoni Artigas, Phd
role: STUDY_DIRECTOR
References:
citation: Turon M, Fernandez-Gonzalo S, Jodar M, Goma G, Montanya J, Hernando D, Bailon R, de Haro C, Gomez-Simon V, Lopez-Aguilar J, Magrans R, Martinez-Perez M, Oliva JC, Blanch L. Feasibility and safety of virtual-reality-based early neurocognitive stimulation in critically ill patients. Ann Intensive Care. 2017 Dec;7(1):81. doi: 10.1186/s13613-017-0303-4. Epub 2017 Aug 2.