Clinical trial NCT01261091: Early Tracheostomy in Ventilated Stroke Patients
Official title: Stroke-Related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical Care Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Intracerebral Hemorrhage
Subarachnoid Hemorrhage
Keywords: Neurocritical Care
Ischemic Stroke
Intracerebral Hemorrhage
Subarachnoid Hemorrhage
Tracheostomy
Tracheotomy
Percutaneous Dilatative Tracheostomy
Weaning
Ventilation
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. If they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. This so called tracheostomy might be associated with advantages such as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for tracheostomy in stroke, however, is not known. This study investigates the potential benefits of early tracheostomy in ventilated critically ill patients with ischemic or hemorrhagic stroke.

Detailed description: Background: Tracheostomy is a common procedure in critical care patients. Advantages of a short tracheal tube compared to a long orotracheal one are the avoidance of laryngeal lesions and sinusitis, facilitation of nursing care and physiotherapy and the reduction of analgosedatives. The optimal point in time for tracheostomy is still unknown, but it is commonly done not later than 2-3 weeks and after one or several failed extubation trials. Studies in different sets of critical care patients have suggested additional advantages of early tracheostomy: less pneumonias and other complications, more patient comfort, less analgosedation, shorter duration of ventilation and of ICU stay. These questions have not been looked at in non-traumatic neurocritical care patients, although these might have a special weaning benefit by early tracheostomy, being mainly compromised in securing their airway, but not in breathing.

Method: Non-traumatic Neurocritical care patients with ischemic strokes, intracerebral hemorrhage or subarachnoid hemorrhage so severly affected that 2 weeks of ventilation need are estimated, are principally eligible for the study. After randomization, one group receives tracheostomy within the first 3 days after intubation. The other group stays orotracheally intubated and is either weaned and extubated or receives tracheostomy within 7 to 14 days after intubation. Tracheostomy is done as percutaneous dilatation by neurologists.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* informed consent from legal representative
* non-traumatic cerebrovascular disease
* Estimated ventilation need for at least 2 weeks

Exclusion Criteria:

* age \< 18 years
* informed consent not obtainable
* intubated for more than 3 days
* death within 3 weeks likely
* severe chronic pulmonary disease
* severe chronic cardiac disease
* emergency situation
* intracranial pressure difficult to control
* need for a permanent tracheostoma
* contraindications for dilatative tracheostomy
* severe coagulopathy
* severe respiration difficulties
* intubation/extubation/tube exchange difficulties

Primary outcomes:
measure: Intensive Care Unit Length of Stay (ICU-LOS)
timeFrame: open
Secondary outcomes:
measure: Time of ICU-dependence
timeFrame: open
measure: Functional Outcome
timeFrame: admission, discharge, at 6 months
measure: Mortality
timeFrame: during stay, after 6 months
measure: Hospital Length of Stay
timeFrame: open
measure: Duration of Ventilation
timeFrame: open
measure: Duration and Quality of Weaning
timeFrame: Within ventilation time
measure: Time of Analgosedation Dependence
timeFrame: within ICU-LOS
measure: Vasopressor Dependence
timeFrame: within ICU-LOS
measure: Time of Antibiotic Treatment
timeFrame: within ICU-LOS
measure: Pneumonias
timeFrame: within ICU-LOS
measure: Occurrence and Duration of Sepsis
timeFrame: within ICU-LOS
measure: Number and type of complications associated with the procedure
timeFrame: 10 days post tracheostomy
measure: Cost of Treatment
timeFrame: within ICU-LOS
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: NeuroIntensive Care Unit, Department of Neurology, University Hospital Heidelberg
Study officials:
affiliation: Department of Neurology, University of Heidelberg
name: Bösel Julian, Dr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, University of Heidelberg
name: Thorsten Steiner, Prof, MD
role: STUDY_CHAIR
References:
citation: Bosel J, Schiller P, Hook Y, Andes M, Neumann JO, Poli S, Amiri H, Schonenberger S, Peng Z, Unterberg A, Hacke W, Steiner T. Stroke-related Early Tracheostomy versus Prolonged Orotracheal Intubation in Neurocritical Care Trial (SETPOINT): a randomized pilot trial. Stroke. 2013 Jan;44(1):21-8. doi: 10.1161/STROKEAHA.112.669895. Epub 2012 Nov 29.