Early Tracheostomy in Ventilated Stroke Patients (SETPOINT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julian Boesel, Heidelberg University
ClinicalTrials.gov Identifier:
NCT01261091
First received: December 15, 2010
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Ischemic Stroke
Intracerebral Hemorrhage
Subarachnoid Hemorrhage
Procedure: Early Tracheostomy
Procedure: Late Tracheostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stroke-Related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical Care Trial

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Intensive Care Unit Length of Stay (ICU-LOS) [ Time Frame: open ] [ Designated as safety issue: No ]
    The primary endpoint is assessed as days from admission to until discharge from the intensive care unit.


Secondary Outcome Measures:
  • Time of ICU-dependence [ Time Frame: open ] [ Designated as safety issue: No ]
    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.)

  • Functional Outcome [ Time Frame: admission, discharge, at 6 months ] [ Designated as safety issue: Yes ]
    This secondary endpoint is assessed as the modified Rankin Scale (mRS) at the above named timepoints.

  • Mortality [ Time Frame: during stay, after 6 months ] [ Designated as safety issue: Yes ]
    This secondary endpoint is assessed as time and type of death during the ICU-stay and 6 months after admission.

  • Hospital Length of Stay [ Time Frame: open ] [ Designated as safety issue: No ]
    This secondary endpoint is assessed as days spent at the recruiting hospital from admission to discharge.

  • Duration of Ventilation [ Time Frame: open ] [ Designated as safety issue: No ]
    This secondary endpoint is assessed as half-days on the ventilator until the patient is ventilator-independent for 24 h.

  • Duration and Quality of Weaning [ Time Frame: Within ventilation time ] [ Designated as safety issue: No ]
    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.

  • Time of Analgosedation Dependence [ Time Frame: within ICU-LOS ] [ Designated as safety issue: No ]
    This secondary endpoint is assessed as half-days requiring the application of sedatives and analgesics which are also specified.

  • Vasopressor Dependence [ Time Frame: within ICU-LOS ] [ Designated as safety issue: No ]
    This secondary endpoint is assessed as half-days spent under vasopressors.

  • Time of Antibiotic Treatment [ Time Frame: within ICU-LOS ] [ Designated as safety issue: No ]
    This secondary endpoint is assessed as half-days under antibiotic treatment

  • Pneumonias [ Time Frame: within ICU-LOS ] [ Designated as safety issue: Yes ]
    This secondary endpoint is assessed as episodes (pre-defined by diagnostic criteria) of pneumonia.

  • Occurrence and Duration of Sepsis [ Time Frame: within ICU-LOS ] [ Designated as safety issue: Yes ]
    This secondary endpoint is assessed as the number of episodes and duration of sepsis as pre-defined by diagnostic criteria.

  • Number and type of complications associated with the procedure [ Time Frame: 10 days post tracheostomy ] [ Designated as safety issue: Yes ]
    This secondary endpoint is assessed as the number and types of complications arelated to tracheostomy (i.e. bleeding, mispositioning, malfunction, replacement demand,etc.).

  • Cost of Treatment [ Time Frame: within ICU-LOS ] [ Designated as safety issue: No ]
    This secondary endpoint is assessed as the total ICU-costs etsimated by length of stay and severety-derived DRG-multiplicator of each individual patient.


Enrollment: 60
Study Start Date: September 2009
Study Completion Date: April 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261091

Locations
Germany
NeuroIntensive Care Unit, Department of Neurology, University Hospital Heidelberg
Heidelberg, Germany, D-69120
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Julian Boesel, PD Dr.med., Attending Neurology, Director NCCU, Heidelberg University
ClinicalTrials.gov Identifier: NCT01261091     History of Changes
Other Study ID Numbers: S-060/2009
Study First Received: December 15, 2010
Last Updated: April 23, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
Neurocritical Care
Ischemic Stroke
Intracerebral Hemorrhage
Subarachnoid Hemorrhage
Tracheostomy
Tracheotomy
Percutaneous Dilatative Tracheostomy
Weaning
Ventilation

Additional relevant MeSH terms:
Hemorrhage
Ischemia
Stroke
Cerebral Infarction
Subarachnoid Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Intracranial Hemorrhages

ClinicalTrials.gov processed this record on July 22, 2014