Early Tracheostomy in Ventilated Stroke Patients (SETPOINT)

Stroke-Related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical Care Trial

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; Subarachnoid Hemorrhage; Intracerebral Hemorrhage
• Intervention / Treatment: Procedure: Early Tracheostomy; Procedure: Late Tracheostomy

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, D-69120
    • NeuroIntensive Care Unit, Department of Neurology, University Hospital Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Tracheostomy; Patients randomized to early tracheostomy receive (preferably dilatative) tracheostomy within 3 days from intubation.	Procedure: Early Tracheostomy; Tracheostomy is performed as percutaneous dilatative tracheostomy by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.
Active Comparator: 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.	Procedure: Late Tracheostomy; Tracheostomy is performed as percutaneous dilatative tracheostomy by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of ICU-dependence	This secondary endpoint is assessed as days from admission to a pre-defined status that would allow discharge from ICU (absence of active infection, vasopressors, pulmonary and cardial instability etc.)	open
Functional Outcome	This secondary endpoint is assessed as the modified Rankin Scale (mRS) at the above named timepoints.	admission, discharge, at 6 months
Mortality	This secondary endpoint is assessed as time and type of death during the ICU-stay and 6 months after admission.	during stay, after 6 months
Hospital Length of Stay	This secondary endpoint is assessed as days spent at the recruiting hospital from admission to discharge.	open
Duration of Ventilation	This secondary endpoint is assessed as half-days on the ventilator until the patient is ventilator-independent for 24 h.	open
Duration and Quality of Weaning	This secondary endpoint is assessed as half-days spent under the possible application of a weaning protocol, and spent within specific phases of such a protocol.	Within ventilation time
Time of Analgosedation Dependence	This secondary endpoint is assessed as half-days requiring the application of sedatives and analgesics which are also specified.	within ICU-LOS
Vasopressor Dependence	This secondary endpoint is assessed as half-days spent under vasopressors.	within ICU-LOS
Time of Antibiotic Treatment	This secondary endpoint is assessed as half-days under antibiotic treatment	within ICU-LOS
Pneumonias	This secondary endpoint is assessed as episodes (pre-defined by diagnostic criteria) of pneumonia.	within ICU-LOS
Occurrence and Duration of Sepsis	This secondary endpoint is assessed as the number of episodes and duration of sepsis as pre-defined by diagnostic criteria.	within ICU-LOS
Number and type of complications associated with the procedure	This secondary endpoint is assessed as the number and types of complications arelated to tracheostomy (i.e. bleeding, mispositioning, malfunction, replacement demand,etc.).	10 days post tracheostomy
Cost of Treatment	This secondary endpoint is assessed as the total ICU-costs etsimated by length of stay and severety-derived DRG-multiplicator of each individual patient.	within ICU-LOS

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Bösel Julian, Dr, MD, Department of Neurology, University of Heidelberg; Study Chair: Thorsten Steiner, Prof, MD, Department of Neurology, University of Heidelberg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: December 15, 2010
• First Submitted That Met QC Criteria: December 15, 2010
• First Posted (Estimate): December 16, 2010

Study Record Updates

• Last Update Posted (Estimate): April 24, 2014
• Last Update Submitted That Met QC Criteria: April 23, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Weaning; Subarachnoid Hemorrhage; Ischemic Stroke; Tracheostomy; Ventilation; Neurocritical Care; Intracerebral Hemorrhage; Tracheotomy; Percutaneous Dilatative Tracheostomy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Stroke; Ischemic Stroke; Hemorrhage; Subarachnoid Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: S-060/2009