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

NCT01176214 | Terminated Phase 2

• 1 other identifier: WEANING-Study2010
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Intracerebral Hemorrhage

Keywords

supratentorial intracerebral hemorrhage; tracheostomy; sedation; weaning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

  90 days

Study Arms (2)

early tracheostomy

EXPERIMENTAL

see study description

Procedure: Early tracheostomy

late tracheostomy

ACTIVE COMPARATOR

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

Interventions

Early tracheostomy PROCEDURE

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.

early tracheostomy

Late tracheostomy PROCEDURE

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

late tracheostomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University or Erlangen-Nuremberg

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hagen B Huttner, MD

  Department of Neurology, University of Erlangen-Nuremberg, Germany

  PRINCIPAL INVESTIGATOR

• Martin Köhrmann, MD

  Department of Neurology, University of Erlangen, Germany

  STUDY DIRECTOR

• Dimitre Staykov, MD

  Department of Neurology, University of Erlangen, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: August 5, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

DE (1)