Influence of Patient/Ventilador Decoupling in Neurocognitive and Psychopathological Sequelae in I… (NCT02390024) | Clinical Trial Compass
CompletedNot Applicable
Influence of Patient/Ventilador Decoupling in Neurocognitive and Psychopathological Sequelae in ICU Patients
Spain156 participantsStarted 2015-06
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.