Intracerebral Hemorrhage
Conditions
Keywords
supratentorial intracerebral hemorrhage, tracheostomy, sedation, weaning
Brief 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
Interventions
PROCEDUREEarly 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.
PROCEDURELate 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
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative time requiring mechanical ventilation and Overall duration of neurocritical care | 30 days | Primary End-points: * Cumulative time requiring mechanical ventilation * Overall duration of neurocritical care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of respirator-associated pneumonia | 30 days | — |
| Cumulative consumption of sedative drugs | 30 days | — |
| Incidence of episodes with increased intracranial pressure | 30 days | — |
| In-hospital mortality | 30 days | — |
| 3-months functional outcome (mRS) | 90 days | functional outcome after 3 months using the modified Rankin Scale |
Countries
Germany
Outcome results
None listed