Delirium, Agitation/Sedation, Pain and Dyspnea in Respiratory Intensive Care Unit (NIVILIUM) (NCT03880084) | Clinical Trial Compass
UnknownNot Applicable
Delirium, Agitation/Sedation, Pain and Dyspnea in Respiratory Intensive Care Unit (NIVILIUM)
Italy92 participantsStarted 2019-08-01
Plain-language summary
Non-Invasive Mechanical Ventilation (NIV) has been increasingly used in the treatment of acute respiratory failure. Notwithstanding failure rates still remains high, ranging from 5% to 60%. The onset of delirium, agitation, pain and dyspnea may contribute to reduce the success rate of non invasive ventilation treatment. The aim of this study is to assess the incidence and impact of delirium, agitation, pain and dyspnea on clinical outcomes in a population of patient admitted to Respiratory Intensive Care Unit undergoing Non-Invasive Mechanical Ventilation for Acute Respiratory Failure.
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:
* patients with acute respiratory failure admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena undergoing non invasive mechanical ventilation
Exclusion Criteria:
* age lower than 18
* Glasgow Coma Scale lower than 10 within 24 hours from Respiratory Intensive Care Unit admission
* need for immediate orotracheal intubation
* pregnancy
* previously established psychiatric disease or dementia
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
Incidence of delirium
Timeframe: 7 days from Respiratory Intensive Care Unit admission
2
Incidence of agitation
Timeframe: 7 days from Respiratory Intensive Care Unit admission
3
Incidence of pain
Timeframe: 7 days from Respiratory Intensive Care Unit admission
4
Incidence of dyspnea
Timeframe: 7 days from Respiratory Intensive Care Unit admission