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

Study Overview
=================
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

Official Title
-----------------
Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings

Conditions
-----------------
Intracerebral Hemorrhage

Intervention / Treatment
-----------------
* Procedure: Early tracheostomy
* Procedure: Late tracheostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early tracheostomy<br>see study description | Procedure: Early tracheostomy<br>* 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.<br>|
| Active Comparator: late tracheostomy<br>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 | Procedure: Late tracheostomy<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative time requiring mechanical ventilation and Overall duration of neurocritical care | Primary End-points: Cumulative time requiring mechanical ventilation Overall duration of neurocritical care | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | functional outcome after 3 months using the modified Rankin Scale | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
supratentorial intracerebral hemorrhage, tracheostomy, sedation, weaning