Influence of Patient/Ventilador Decoupling in Neurocognitive and Psychopathological Sequelae in ICU Patients (PVI-NCOG)

Influence of Persistent Patient / Ventilator Decoupling in Cognitive and Psychopathological Sequelae in Critically Ill Patients: A Multicenter Clinical and Mechanisticstudy

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Device: Invasive Mechanical Ventilation

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.

• Study Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

Study Locations

• Spain
  • Barcelon
    • Sabadell, Barcelon, Spain, 08208
      • Corporacion Sanitaria Parc Tauli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• No authorization of the family or patient inclusion.
• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critically ill patients; Mechanical Ventilation	Device: Invasive Mechanical Ventilation; 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 Names: Asynchronies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-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'	1year after ICU discharge
Short-term anxiety and depression symptoms	Measured by:: Hospital Anxiety and Depression Scale (HADS)	1month after ICU discharge
Short-term Post-traumatic Stress Disorder	Measured by: Post Traumatic Stress Syndrome: Davidson Trauma Scale	1month after ICU discharge
Long-term anxiety and depression symptoms	Measured by: Hospital Anxiety and Depression Scale (HADS)	1year after ICU discharge
Long-term Post-traumatic Stress Disorder	Measured by: Post Traumatic Stress Syndrome: Davidson Trauma Scale	1year after ICU discharge

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: Hospital Mutua de Terrassa; Althaia Xarxa Assistencial Universitària de Manresa
• Investigators: Principal Investigator: Lluís Blanch Torra, PhD, Fundacio Parc Tauli

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: March 10, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Cognition; Mechanical Ventilation; Asynchronies
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: PI13/02204