CompletedNot Applicable

Early Tracheostomy in Ventilated Stroke Patients 2

Germany380 participantsStarted 2015-05

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Functional outcome

Timeframe: 6 months

Trial details

NCT IDNCT02377167

SponsorUniversity Hospital Heidelberg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01