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

Intracerebral Hemorrhage Clinical Trial

— WEANING  

Official title:

Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01176214
• Other study ID #: WEANING-Study2010
• Status: Terminated
• Phase: Phase 2
• First received: July 26, 2010
• Last updated: April 25, 2014
• Start date: July 2010
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

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.
• 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

Locations

Country	Name	City	State
Germany	University or Erlangen-Nuremberg	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of respirator-associated pneumonia		30 days	Yes
Secondary	Cumulative consumption of sedative drugs		30 days	No
Secondary	Incidence of episodes with increased intracranial pressure		30 days	Yes
Secondary	In-hospital mortality		30 days	Yes
Secondary	3-months functional outcome (mRS)	functional outcome after 3 months using the modified Rankin Scale	90 days	No