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

University of Erlangen-Nürnberg Medical School

Status and phase: Terminated; Phase 2

Conditions: Intracerebral Hemorrhage

Treatments: Procedure: Early tracheostomy; Procedure: Late tracheostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01176214

WEANING-Study2010

Details and patient eligibility

About

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

Enrollment: 7 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

early tracheostomy

Experimental group

Description:

see study description

Treatment:

Procedure: Early tracheostomy

late tracheostomy

Active Comparator group

Description:

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

Treatment:

Procedure: Late tracheostomy