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

Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings

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

Study Overview

• Status: Terminated
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Procedure: Early tracheostomy; Procedure: Late tracheostomy

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • University or Erlangen-Nuremberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: early tracheostomy; see study description	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.
Active Comparator: 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	Procedure: 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

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
In-hospital mortality		30 days
Incidence of respirator-associated pneumonia		30 days
Cumulative consumption of sedative drugs		30 days
Incidence of episodes with increased intracranial pressure		30 days
3-months functional outcome (mRS)	functional outcome after 3 months using the modified Rankin Scale	90 days

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: Hagen B Huttner, MD, Department of Neurology, University of Erlangen-Nuremberg, Germany; Study Director: Martin Köhrmann, MD, Department of Neurology, University of Erlangen, Germany; Study Director: Dimitre Staykov, MD, Department of Neurology, University of Erlangen, Germany

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: August 4, 2010
• First Posted (Estimate): August 5, 2010

Study Record Updates

• Last Update Posted (Estimate): April 28, 2014
• Last Update Submitted That Met QC Criteria: April 25, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: sedation; weaning; tracheostomy; supratentorial intracerebral hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: WEANING-Study2010