RKNE_UNIV_HOSPITAL_HEIDELBERG_SETPOINT2

Stroke-Related Early Tracheostomy Versus Prolonged Orotracheal Intubation in Neurocritical Care Trial 2

Inclusion Criteria:

Age 18 years or older
informed consent from legal representative
non-traumatic cerebrovascular disease
Estimated ventilation need for at least 2 weeks
The clinical judgement of the attending neurointensivist
principle indication for tracheostomy
Exclusion Criteria:

Premorbid modified Rankin Score (mRS)>1
Artificial ventilation for more than 4 days
Severe chronic pulmonary disease requiring supplemental oxygen, or evidence of CO2 retention on admission serum analysis (HCO3≥30)
Severe chronic cardiac disorder
Any emergency situation compromising the patient's well-being or ability to undergo tracheostomy in the study time-frame
Intracranial pressure (ICP) persistently > 25cmH2O
Difficult airway management, anticipated problems with extubation / re-intubation,
Need for a permanent surgical tracheostomy
Contraindications for a percutaneous tracheostomy (see below)
High oxygenation requirements: Positive end-expiratory pressure > 12, or fraction of inspired oxygen > 0.6)
Pregnancy
Participation in any other interventional trial
Life expectancy < 3 weeks
Patient/family unlikely to opt for at least 3 weeks of aggressive therapy prior to consideration of transition to comfort measures/discontinuation of life support measures
N/A
NCT02377167
All Other
Stroke, Surgery
Phani Kantamneni, M.D.
PCORI (Patient-Centered Outcomes Research Institute)
Mandy Smith
  • Kadlec Regional Medical Center
  • Kadlec Research