Entropy Analysis and Complex Patient-ventilator Interactions During Mechanical Ventilation (NCT04128124) | Clinical Trial Compass
CompletedNot Applicable
Entropy Analysis and Complex Patient-ventilator Interactions During Mechanical Ventilation
Spain107 participantsStarted 2019-09-01
Plain-language summary
Complex patterns of patient-ventilator interactions could be miscalculated by visual observation of mechanical ventilator screens or current algorithms based on physiologic waveforms to detect patient-ventilator asynchronies. Therefore, we aim to characterize, validate and study the clinical distribution and implications of an automated and personalized non-invasive tool based on Entropy to detect Complex Patient-Ventilator Interactions (CP-VI) during mechanical ventilation, defined as breathing pattern change and/or clusters of asynchronies, over the signals of airway pressure (Paw) and airway flow (Flow).
Who can participate
Age range
18 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:
* Admission to a ICU bed equipped with BetterCare software and intubated fo mechanical ventilation expected to last more than 24hs
* patients who develops a self-extubation episode or a spontaneous breathing trial.
Exclusion Criteria:
* \<18 years
* \<48hs of recorded data
* moribund state
* admission for organ donation
* chest tubes with suspected bronchopleural fistula
* accidental extubation
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.
What they're measuring
1
validation of entropy to detect complex patient-ventilator interactions
Timeframe: 3 months
2
successful extubation (remaining free of mechanical ventilation 72 hours after extubation) in those patients with complex patient-ventilator interactions