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

This study is currently recruiting participants.
Verified March 2013 by University of Erlangen-Nürnberg Medical School
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01176214
First received: July 26, 2010
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Intracerebral Hemorrhage
 Procedure: Early tracheostomy
Procedure: Late tracheostomy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Cumulative time requiring mechanical ventilation and Overall duration of neurocritical care [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    Primary End-points:

    • Cumulative time requiring mechanical ventilation
    • Overall duration of neurocritical care


Secondary Outcome Measures:
  • Incidence of respirator-associated pneumonia [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Cumulative consumption of sedative drugs [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Incidence of episodes with increased intracranial pressure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • In-hospital mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • 3-months functional outcome (mRS) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    functional outcome after 3 months using the modified Rankin Scale


Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176214

Contacts
Contact: Hagen B. Huttner, MD +4991318544523 hagen.huttner@uk-erlangen.de
Contact: Dimitre Staykov, MD +4991318544539 dimitre.staykov@uk-erlangen.de

Locations
Germany
University or Erlangen-Nuremberg Recruiting
Erlangen, Germany, 91054
Contact: Hagen B Huttner, MD     +4991318544523     hagen.huttner@uk-erlangen.de    
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01176214     History of Changes
Other Study ID Numbers: WEANING-Study2010
Study First Received: July 26, 2010
Last Updated: March 1, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University of Erlangen-Nürnberg Medical School:
supratentorial intracerebral hemorrhage
tracheostomy
sedation
weaning

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013