A Study of Positive Long-Term Functional Outcomes with Early Tracheostomy in Ventilated Stroke Patients
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 16-003029
NCT ID: NCT02377167
Sponsor Protocol Number: SETPOINT2
About this study
The purpose of this study is to test for the long-term outcomes in function for stroke patients who get an early tracheostomy, versus those who have prolonged orotracheal intubation.
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. Preliminary data from a pilot study of early tracheostomy in patients with hemorrhagic or ischemic stroke suggest that such patients may also have improved survival and long-term functional outcomes, but a large, multicenter clinical trial is needed to confirm these findings.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Age 18 years or older
- One of the following confirmed admission diagnoses
- Non-traumatic acute ischemic infarction
- Non-traumatic intracerebral hemorrhage
- Non-traumatic subarachnoid hemorrhage
- Informed consent from patient or legal representative
- Estimated ventilation need for at least 2 weeks
- The clinical judgement of the attending neurointensivist
- Principle indication for tracheostomy at least one of the following
- Ongoing demand of suctioning bronchotracheal secretions
- CNS-related respiratory insufficiency
- Aspiration or danger of aspiration due to dysphagia
Exclusion Criteria
- Premorbid modified Rankin Score >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 > 25mmHg
- Difficult airway management, anticipated problems with extubation / re-intubation
- Contraindications for a percutaneous tracheostomy
- Oxygenation impairment, Positive end-expiratory pressure > 12, or fraction of inspired oxygen > 0.6
- Need for a permanent surgical tracheostomy
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator William Freeman, M.D. |
Closed for enrollment |
|
More information
Publications
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Optimal timing of tracheostomy in ventilated patients with severe stroke is unclear. We aimed to investigate feasibility, safety, and potential advantages of early tracheostomy in these intensive care unit (ICU) patients.
Read More on PubMed