Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT02377167
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02377167
Study Brief:
Protocol Section:
NCT02377167