NCT01176214

WEANING-Study: "Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings

Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
PROCEDURE	Early tracheostomy	Patients with supratentorial ICH who require mechanical ventilation, fulfill the inclusion criteria, and have been randomized to the "treatment arm" will receive an early tracheostomy within 72h after symptom onset.
PROCEDURE	Late tracheostomy	Compared to the "early tracheostomy"-group, those patients who have been randomized to "late tracheostomy" will undergo conventional tracheostomy between day 12 - 14 if extubation fails

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2010-08-05
• Last updated: 2014-04-28

Locations

1 site across 1 country: Germany