Early Tracheostomy in Ventilated Stroke Patients

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: November 2011

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Early Tracheostomy
    • Patients randomized to early tracheostomy receive (preferably dilatative) tracheostomy within 3 days from intubation.
  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Intensive Care Unit Length of Stay (ICU-LOS)
    • Time Frame: open
      Safety Issue?: No

Secondary Measures

  • Time of ICU-dependence
    • Time Frame: open
      Safety Issue?: No
  • Functional Outcome
    • Time Frame: admission, discharge, at 6 months
      Safety Issue?: Yes
  • Mortality
    • Time Frame: during stay, after 6 months
      Safety Issue?: Yes
  • Hospital Length of Stay
    • Time Frame: open
      Safety Issue?: No
  • Duration of Ventilation
    • Time Frame: open
      Safety Issue?: No
  • Duration and Quality of Weaning
    • Time Frame: Within ventilation time
      Safety Issue?: No
  • Time of Analgosedation Dependence
    • Time Frame: within ICU-LOS
      Safety Issue?: No
  • Vasopressor Dependence
    • Time Frame: within ICU-LOS
      Safety Issue?: No
  • Time of Antibiotic Treatment
    • Time Frame: within ICU-LOS
      Safety Issue?: No
  • Pneumonias
    • Time Frame: within ICU-LOS
      Safety Issue?: Yes
  • Occurrence and Duration of Sepsis
    • Time Frame: within ICU-LOS
      Safety Issue?: Yes
  • Number and type of complications associated with the procedure
    • Time Frame: 10 days post tracheostomy
      Safety Issue?: Yes
  • Cost of Treatment
    • Time Frame: within ICU-LOS
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Heidelberg University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Julian Boesel, PD Dr.med., Attending Neurology, Director NCCU – Heidelberg University
  • Overall Official(s)
    • Bösel Julian, Dr, MD, Principal Investigator, Department of Neurology, University of Heidelberg
    • Thorsten Steiner, Prof, MD, Study Chair, Department of Neurology, University of Heidelberg

References

Bösel J, Schiller P, Hook Y, Andes M, Neumann JO, Poli S, Amiri H, Schönenberger 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.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01261091