Early Tracheostomy in Ventilated Stroke Patients

NCT ID: NCT01261091

Last Updated: 2014-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-04-30

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.

Conditions

Ischemic Stroke; Intracerebral Hemorrhage; Subarachnoid Hemorrhage

Study Design

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

Study Groups

Early Tracheostomy

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

Group Type: EXPERIMENTAL

Early Tracheostomy

Intervention Type: PROCEDURE

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

Prolonged Intubation

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.

Group Type: ACTIVE_COMPARATOR

Late Tracheostomy

Intervention Type: PROCEDURE

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

Interventions

Early Tracheostomy

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

Intervention Type: PROCEDURE

Late Tracheostomy

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

Intervention Type: PROCEDURE

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

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

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Julian Boesel

PD Dr.med., Attending Neurology, Director NCCU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bösel Julian, Dr, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University of Heidelberg

Thorsten Steiner, Prof, MD

Role: STUDY_CHAIR

Department of Neurology, University of Heidelberg

Locations

NeuroIntensive Care Unit, Department of Neurology, University Hospital Heidelberg

Heidelberg, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 23204058 (View on PubMed)

Other Identifiers

S-060/2009

Identifier Type: -

Identifier Source: org_study_id