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

This study is currently recruiting participants.
Verified February 2014 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: February 25, 2014
Last verified: February 2014

July 26, 2010
February 25, 2014
July 2010
June 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01176214 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
WEANING-Study: "Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings
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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Intracerebral Hemorrhage
  • 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.
  • 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
  • Experimental: early tracheostomy
    see study description
    Intervention: Procedure: Early tracheostomy
  • 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
    Intervention: Procedure: Late tracheostomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
June 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years to 85 Years
No
Contact: Hagen B. Huttner, MD +4991318544523 hagen.huttner@uk-erlangen.de
Contact: Dimitre Staykov, MD +4991318544539 dimitre.staykov@uk-erlangen.de
Germany
 
NCT01176214
WEANING-Study2010
No
University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
Not Provided
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
University of Erlangen-Nürnberg Medical School
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP