Influence of Patient/Ventilador Decoupling in Neurocognitive and Psychopathological Sequelae in ICU Patients

NCT02390024 | Completed DMC

• 1 other identifier: PI13/02204
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanical ventilation (MV) is a vital support tool for critically ill patients. However, it may present several adverse effects, such as the development of cognitive and psychopathological alterations. Patient-ventilator asynchronies occur frequently since the beginning of the MV. These asynchronies are associated with poor clinical outcome and could be responsible for the neuronal changes causing these alterations. The objective of this project is to analyze the influence of patient-ventilation asynchronies in the development of long-term cognitive/psychopathological impairments and to explore the molecular mechanisms that could explain of these alterations. An exploratory, observational, multicenter, non-interventionist study will be performed in 150 ICU patients. The continuous recording of asynchronies and other clinical variables during ICU stay and the results of neuropsychological assessments will enable to identify clinical clusters associated with cognitive/psychopathological impairments.

Conditions

Critical Illness

Keywords

Mechanical Ventilation; Asynchronies; Cognition

Outcome Measures

Primary Outcomes (1)

• Short-term neurocognitive alterations

  This outcome will be a composite outcome measured by: Attention / Verbal Working Memory: Digits subtest WAIS III Attention / Visual Working Memory: Spatial Span subtest of the WMS III Verbal Learning and Memory: Auditory Verbal Learning Test Speed of Information Processing: Symbol Search subtest of WAIS III Sequencing and alternating stimuli: Trail Making Test Inhibition of the automatic reply: Stroop Test Verbal Fluency: FAS Semantic Verbal Fluency: Animals 1'

  1month after ICU discharge

Secondary Outcomes (5)

• Long-term neurocognitive alterations

  1year after ICU discharge

• Short-term anxiety and depression symptoms

  1month after ICU discharge

• Short-term Post-traumatic Stress Disorder

  1month after ICU discharge

• Long-term anxiety and depression symptoms

  1year after ICU discharge

• Long-term Post-traumatic Stress Disorder

  1year after ICU discharge

Study Arms (1)

Critically ill patients

Mechanical Ventilation

Device: Invasive Mechanical Ventilation

Interventions

Invasive Mechanical Ventilation DEVICE

Mechanical ventilation parameters will be monitorized during the ICU stay in all patients Four types of ventilators will be used: Servo Dräger Evita XL Dräger Evita 4 Puritan Bennet 840

Also known as: Asynchronies

Critically ill patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients undergoing mechanical ventilation and monitored with and advanced continuous monitoring system.

You may qualify if:

• Aged 18 to 80 years old.
• No neurological disease
• No evidence of COPD.
• Patients within the following 24 hours at endotracheal intubation and who are clinically expected to receive \> 72 hours of mechanical ventilation

You may not qualify if:

• Age outside the limits.
• Patients with prior neurological disease or focal brain damage prior to admission to the ICU
• Patients with serious psychiatric illness or mental retardation.
• Time monitoring of asynchrony \< 80% of the total duration of mechanical ventilation.
• Patients who develop secondary complications (infections, stroke, brain damage or structural TC acquired) after discharge from ICU (during hospital stay) that could compromise the results of neuropsychological assessment.
• Patients with moderate to severe cognitive impairment previous to ICU stay (Short form IQCODE \> 57 score)

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Althaia Xarxa Assistencial Universitària de Manresa: collaborator
• Hospital Mutua de Terrassa: collaborator

Study Sites (1)

Corporación Sanitaria Parc Taulí

Sabadell, Barcelon, 08208, Spain

Location

Related Publications (1)

• Fernandez-Gonzalo S, Navarra-Ventura G, Bacardit N, Goma Fernandez G, de Haro C, Subira C, Lopez-Aguilar J, Magrans R, Sarlabous L, Aquino Esperanza J, Jodar M, Rue M, Ochagavia A, Palao DJ, Fernandez R, Blanch L. Cognitive phenotypes 1 month after ICU discharge in mechanically ventilated patients: a prospective observational cohort study. Crit Care. 2020 Oct 21;24(1):618. doi: 10.1186/s13054-020-03334-2.

  PMID: 33087171 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lluís Blanch Torra, PhD

  Fundació Parc Taulí

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Fundació Parc Taulí

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 17, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

ES (1)