Early Tracheostomy in Ventilated Stroke Patients

NCT01261091 | Completed

• 1 other identifier: S-060/2009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Intracerebral Hemorrhage; Subarachnoid Hemorrhage

Keywords

Neurocritical Care; Ischemic Stroke; Intracerebral Hemorrhage; Subarachnoid Hemorrhage; Tracheostomy; Tracheotomy; Percutaneous Dilatative Tracheostomy; Weaning; Ventilation

Outcome Measures

Primary Outcomes (1)

• Intensive Care Unit Length of Stay (ICU-LOS)

  The primary endpoint is assessed as days from admission to until discharge from the intensive care unit.

  open

Secondary Outcomes (13)

• Time of ICU-dependence

  open

• Functional Outcome

  admission, discharge, at 6 months

• Mortality

  during stay, after 6 months

• Hospital Length of Stay

  open

• Duration of Ventilation

  open

Study Arms (2)

Early Tracheostomy

EXPERIMENTAL

Patients randomized to early tracheostomy receive (preferably dilatative) tracheostomy within 3 days from intubation.

Procedure: Early Tracheostomy

Prolonged Intubation

ACTIVE COMPARATOR

Patients randomized to this arm will be tried to wean off the ventilator and get (an) extubation trial(s) if regarded feasible. In case of failure or non-feasibility, they receive tracheostomy between days 7 to 14 from intubation.

Procedure: Late Tracheostomy

Interventions

Early Tracheostomy PROCEDURE

Tracheostomy is performed as percutaneous dilatative tracheostomy by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.

Early Tracheostomy

Late Tracheostomy PROCEDURE

Tracheostomy is performed as percutaneous dilatative tracheostomy by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.

Prolonged Intubation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

NeuroIntensive Care Unit, Department of Neurology, University Hospital Heidelberg

Heidelberg, D-69120, Germany

Location

Related Publications (1)

• 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.

  PMID: 23204058 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage; Subarachnoid Hemorrhage; Respiratory Aspiration

Condition Hierarchy (Ancestors)

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

Study Officials

• Bösel Julian, Dr, MD

  Department of Neurology, University of Heidelberg

  PRINCIPAL INVESTIGATOR

• Thorsten Steiner, Prof, MD

  Department of Neurology, University of Heidelberg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.med., Attending Neurology, Director NCCU

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 16, 2010
• Study Start: September 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: April 1, 2012
• Last Updated: April 24, 2014

Record last verified: 2014-04

Locations

DE (1)