Early Tracheostomy in Ventilated Stroke Patients "SETPOINT"

Completed

Phase N/A Results N/A

Trial Description

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

Interventions

  • Early Tracheostomy Procedure
    Intervention Desc: Tracheostomy is performed as percutaneous dilatative tracheostomy by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.
    ARM 1: Kind: Experimental
    Label: Early Tracheostomy
    Description: Patients randomized to early tracheostomy receive (preferably dilatative) tracheostomy within 3 days from intubation.
  • Late Tracheostomy Procedure
    Intervention Desc: Tracheostomy is performed as percutaneous dilatative tracheostomy by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.
    ARM 1: Kind: Experimental
    Label: Prolonged Intubation
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

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

Sponsors