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

Critical Illness Clinical Trial

— PVI-NCOG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390024
• Other study ID #: PI13/02204
• Status: Completed
• Start date: June 2015
• Est. completion date: September 2018

Study information

• Verified date: March 2020
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: September 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness

Intervention

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

Locations

Country	Name	City	State
Spain	Corporación Sanitaria Parc Taulí	Sabadell	Barcelon

Sponsors (3)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Althaia Xarxa Assistencial Universitària de Manresa, Hospital Mutua de Terrassa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Short-term anxiety and depression symptoms	Measured by:: Hospital Anxiety and Depression Scale (HADS)	1month after ICU discharge
Secondary	Short-term Post-traumatic Stress Disorder	Measured by: Post Traumatic Stress Syndrome: Davidson Trauma Scale	1month after ICU discharge
Secondary	Long-term anxiety and depression symptoms	Measured by: Hospital Anxiety and Depression Scale (HADS)	1year after ICU discharge
Secondary	Long-term Post-traumatic Stress Disorder	Measured by: Post Traumatic Stress Syndrome: Davidson Trauma Scale	1year after ICU discharge