Influence of Patient/Ventilador Decoupling in Neurocognitive and Psychopathological Sequelae in ICU Patients
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Observational

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.
    

Detailed description: 
      MV parameters, as well as other physiological variables, will be monitorized during the ICU
      stay in all patients. A neurocognitive and psychopathological assessment will be administed
      in all patients at 1-month and 1-year follow up.

      After data collection, an asynchronies index will be calculated. A clusters analysis, based
      on clinical variables and asynchronies index, will be performed. The relationship between
      patients' clusters and the neuropsychological/ psychopathological data will be analized.

      CLINICAL STUDY Univariate descriptive analysis: for quantitative variables the mean, standard
      deviation, percentiles 25, 50 and 75, minimum is calculated and maximum. For qualitative
      variables, the absolute and relative frequencies were calculated. Population interval will be
      estimated at 95% confidence level.

      Multivariate analysis: cluster analysis, with the intention to investigate possible
      associations of individuals and characterization of the profile of each cluster. Comparison
      of standardized scores (z) of the neuropsychological variables and asynchronies index between
      clusters will be carried out by parametric or nonparametric techniques, as more appropriate.

      Association of asynchrony with the neuropsychological variables: conditional logistic
      regression (case-control) of the scores of neuropsychological variables (dichotomized) versus
      asynchronies index will be performed, controlling for confounding covariates or factors that
      may have a modifier effect. The multivariate case-control matching will be performed by the
      method of propensity score or by genetic algorithms. The odds ratio and confidence interval
      of 95% was estimated.

      Sample size: has been used rule of thumb for logistic regression models include between 10-15
      cases per covariate. In this case, the sample will consist of 150 patients.
    

Intervention name(s): Invasive Mechanical Ventilation
Intervention type(s): Device
Intervention description(s): 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
Other intervention name(s): Asynchronies
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ICU patients undergoing mechanical ventilation and monitored with and advanced continuous
        monitoring system.
      
Keywords: Mechanical Ventilation; Asynchronies; Cognition