Clinical trial NCT01176214: WEANING-Study: "Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings
Official title: Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Intracerebral Hemorrhage
Keywords: supratentorial intracerebral hemorrhage
tracheostomy
sedation
weaning
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2010-08-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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)

Primary outcomes:
measure: Cumulative time requiring mechanical ventilation and Overall duration of neurocritical care
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of respirator-associated pneumonia
timeFrame: 30 days
measure: Cumulative consumption of sedative drugs
timeFrame: 30 days
measure: Incidence of episodes with increased intracranial pressure
timeFrame: 30 days
measure: In-hospital mortality
timeFrame: 30 days
measure: 3-months functional outcome (mRS)
timeFrame: 90 days
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University or Erlangen-Nuremberg
Study officials:
affiliation: Department of Neurology, University of Erlangen-Nuremberg, Germany
name: Hagen B Huttner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, University of Erlangen, Germany
name: Martin Köhrmann, MD
role: STUDY_DIRECTOR
affiliation: Department of Neurology, University of Erlangen, Germany
name: Dimitre Staykov, MD
role: STUDY_DIRECTOR
References: