WEANING-Study: "Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings (NCT01176214) | Clinical Trial Compass
TerminatedPhase 2
WEANING-Study: "Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings
Stopped: slow recruitment of patients
Germany7 participantsStarted 2010-07
Plain-language summary
Background:
One third of all ICH patients require intubation and mechanical ventilation and 1/3 of all ventilated patients require tracheostomy (i.e.≈10% of all ICH patients require tracheostomy). As shown previously, predisposing factors for tracheostomy are hematoma volume, hemorrhage location, presence of intraventricular hemorrhage (IVH), and occlusive hydrocephalus as well as presence of COPD (Huttner HB et al 2006 CVD).
Sustained restricted vigilance and impaired consciousness after ICH is likely to result in failure of extubation, raise in incidence of ventilator-associated pneumonia, increased amount of sedative drugs and prolonged duration of neurocritical care.
Hence an early tracheostomy may be beneficial in terms of reduced duration of mechanical ventilation.
Basic hypothesis:
Compared to patients with conventional ("late") tracheostomy between day 12 - 14, patients with "early" tracheostomy within 72h after admission will have:
* shorter cumulative time of mechanical ventilation
* less incidence of ventilator-associated pneumonia
* less consumption of sedative drugs
* shorter duration of stay in neurocritical care unit
Randomization:
Consecutive eligible patients are randomly assigned to Either "early" tracheostomy within 72h after hospital admission Or "late" tracheostomy (= control group; undergoing conventional tracheostomy between day 12 - 14 if extubation fails) Both groups receive plastic tracheostomy
Who can participate
Age range
18 Years – 85 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 requiring intubation / mechanical ventilation
* Supratentorial intracerebral hemorrhage (including:)
* primary spontaneous ICH (lobar / deep)
* ICH related to anticoagulant therapy
* with or without intraventricular hemorrhage
* with or without occlusive and / or communicating hydrocephalus
* Hematoma volume \>0 ml and \<60 ml
* Age 18 - 85 years
* Informed consent (legal representative)
Exclusion Criteria:
* Patients with elective intubation/ventilation for EVD placement
* Patients with "do not treat" / "do not resuscitate" orders, severe co- morbidity and life expectancy of less than 3 months
* Absent consent of relatives for invasive (neuro-)critical care
* Contraindication for tracheostomy
* Other than primary supratentorial ICH or supratentorial ICH related to oral anticoagulants
* Pre-existing COPD (known/treated)
* Pre-existing congestive heart failure (≥3 NYHA)
* Pre-existing modified Rankin Scale (≥4)
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
Cumulative time requiring mechanical ventilation and Overall duration of neurocritical care
Timeframe: 30 days
Trial details
NCT IDNCT01176214
SponsorUniversity of Erlangen-Nürnberg Medical School