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

NCT ID: NCT01176214

Last Updated: 2014-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

early tracheostomy

see study description

Group Type: EXPERIMENTAL

Early tracheostomy

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Late tracheostomy

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hagen B Huttner, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University of Erlangen-Nuremberg, Germany

Martin Köhrmann, MD

Role: STUDY_DIRECTOR

Department of Neurology, University of Erlangen, Germany

Dimitre Staykov, MD

Role: STUDY_DIRECTOR

Department of Neurology, University of Erlangen, Germany

Locations

University or Erlangen-Nuremberg

Erlangen, , Germany

Countries

Germany

Other Identifiers

WEANING-Study2010

Identifier Type: -

Identifier Source: org_study_id