Early Tracheostomy in Ventilated Stroke Patients 2 "SETPOINT2"


Phase N/A Results N/A

Eligibility Criteria

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