Weaning From Mechanical Ventilation Comparison of Open-loop Decision Support System and Routine Care (NCT02842944) | Clinical Trial Compass
CompletedNot Applicable
Weaning From Mechanical Ventilation Comparison of Open-loop Decision Support System and Routine Care
France29 participantsStarted 2017-12-12
Plain-language summary
The purpose of this study is to compare mechanical ventilation following advice from the Beacon Caresystem to that of routine care in patients from the state of requiring invasive mechanical ventilation until successful extubation. The Beacon Caresystem will be compared to routine care to investigate whether use of the system results in similar care and reduced time for weaning from mechanical ventilation.
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:
* Patient is on invasive mechanical ventilation more 48 hours
* Age \> 18 years
* Patients are ventilated using Maquet Servo-I, Draeger Infinity V500 or Draeger Evita XL mechanical ventilators in "pressure support", "volume controlled", or "pressure controlled" ventilation modes.
* Haemodynamically stable (mean blood pressure ≥ 65 mmHg)
* Patients or, in the case that the patient is unable, next of kin understand and accept oral and written information describing the study or patient consent retrospectively in case of emergency inclusion.
Exclusion Criteria:
* The absence of an arterial catheter for blood sampling.
* Medical history of home mechanical ventilation
* Severe ARDS (PaO2/FiO2 ≤ 100 mmHg)
* Head trauma or other conditions where intra-cranial pressure may be elevated and tight regulation of arterial CO2 level is paramount.
* Severe neurological patients (Glasgow coma score \<10, neurologic damage with limited prognosis, stroke hemiplegia).
* Known or suspected severe myopathy or neuropathy (including ICU neuromyopathy)
* Quadriplegia
* Severe heart failure
* Broncho alveolar fistula with more than 100ml leakage
* History of home mechanical ventilation
* Pregnancy.
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
Duration of mechanical ventilation
Timeframe: 14 days
2
Time to successful extubation
Timeframe: Successful extubation is defined as ≥ 7 days of unassisted spontaneous breathing after extubation