Individualised Weaning From Mechanical Ventilation in General ICU (NCT03249623) | Clinical Trial Compass
UnknownNot Applicable
Individualised Weaning From Mechanical Ventilation in General ICU
United Kingdom274 participantsStarted 2017-12-11
Plain-language summary
Patients residing in the intensive care unit typically receive mechanical ventilatory support. Selecting the appropriate level of mechanical ventilation is not trivial, and it has been shown that lung protective settings can reduce mortality in patients with lung injury. Despite being a life- saving therapy, duration of mechanical ventilation should be kept at a minimum to reduce effects of immobilization, long-term sedation, patient discomfort, risk of ventilator associated pneumonia, leading to decreasing mortality and economic costs etc. The duration of mechanical ventilation is also an important factor in weaning from ventilatory support, with prolonged ventilator support making the weaning process more difficult.
The purpose of this study is to compare mechanical ventilation following advice from the Beacon Caresystem to that of standard care in general medical intensive care unit (ICU) patients, from the start of requiring invasive mechanical ventilation until successful extubation. The Beacon Caresystem will be compared to standard care to investigate whether use of the system results in similar care or 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 expected to be on invasive mechanical ventilation more 24 hours.
* Age \> 18 years
* Haemodynamically stable (with instability defined by the presence of two or more of the following criteria: acidosis pH \< 7.2, poor urine output \< 0.5ml/kg, use of vasopressors, e.g. noradrenline \> 25 μg/min).
* Patient consent or, in the case that the patient is unable, assent from the next of kin or treating physician following understanding and accept of oral and written information describing the study
Exclusion Criteria:
* The absence of an arterial catheter for blood sampling at study start.
* Medical history of home mechanical ventilation which may lead to prolonged stay in the ICU, including long term oxygen therapy and non-invasive ventilation not associated with sleep apnoa.
* Clinical conditions requiring treatment with extracorporeal membrane oxygenation, i.e. an inspired oxygen of 100% for more than 24 hours.
* Head trauma or other conditions where intra-cranial pressure may be elevated and tight regulation of arterial CO2 level is paramount.
* Primary neurological patients (Glasgow coma score \<10, neurologic damage with limited prognosis, stroke hemiplegia).
* Severe heart failure, classified as grade 4 of the Association of Cardiology guidelines \[2\].
* End stage liver disease.
* Multiple medical ICU admissions, i.e. more than one admission.
* Corrective orthognathic surgery.
* Esophageal surgery.
* Morbidly obese patients defined as eit…
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
Length of mechanical ventilation
Timeframe: Daily assessment of requirement of mechanical ventilation from the time of randomisation until the date of liberation from mechanical ventilation, up to 12 months.
Trial details
NCT IDNCT03249623
SponsorChelsea and Westminster NHS Foundation Trust