Influence of Persistent Patient / Ventilator Decoupling in Cognitive and Psychopathological Sequelae in Critically Ill Patients: A Multicenter Clinical and Mechanisticstudy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Short-term neurocognitive alterations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Short-term neurocognitive alterations
时间窗: 1month after ICU discharge
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'
次要结局
- Long-term anxiety and depression symptoms(1year after ICU discharge)
- 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 Post-traumatic Stress Disorder(1year after ICU discharge)
研究者
Lluis Blanch
Director of the Fundació Parc Taulí
Corporacion Parc Tauli