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.
Background: According to United States data from the National Inpatient Sample, about 1.3% of 1.5 million patients (20,300) hospitalized with ischemic stroke from 2007-2009 underwent tracheostomy - while the number of tracheostomies performed for hemorrhagic stroke is unknown. Historically, mechanically ventilated patients with ischemic or hemorrhagic strokes have had poor functional outcomes, and care of such patients is extremely expensive. Effective interventions to improve survival, improve functional recovery, decrease costs, and increase cost-effectiveness are urgently needed. Early tracheostomy of selected medical and surgical patients allows for dramatically decreased sedation and analgesia, and is associated with improved outcomes. 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.
Method: SETPOINT 2 is a prospective, randomized, controlled, outcome observer-blinded, multicenter, two-armed, comparative trial. Patients are randomized 1:1 to either the experimental group - who undergo percutaneous tracheostomy (PDT) as soon as feasible and within 5 days after intubation ("early tracheostomy") or to the control group ("standard of care" group), in which PDT is performed after day 10 from intubation if the application of an in-house weaning protocol did not lead to successful extubation. Otherwise, no differences in intensive care treatment are intended, and each participating institution's standard operating procedures will be applied to ensure uniform management decisions in fields such as weaning, ventilation, analgesia and sedation, transfusion, and neurological monitoring and management. Blinding to the treatment assignment is impossible for treating physicians, patients and legal representatives as well as for most of the investigators. However, the primary endpoint of long-term outcome and causes of mortality will be assessed by trial-independent adjudicators blinded to the timing of tracheostomy.
The study started as an investigator initiated study which was conducted with limited external funding. Some funding (about 50 000 Euros) was provided from third party funds by the principal investigator and other foundations to provide for data management by the IMBI and other organizational aspects of the study. The principal investigator and the US co-principle investigator-David B. Seder, M.D.) together applied for research funding to several foundations and medical associations and in December 2016 received confirmation of funding from the Patient-Centered Outcomes Research Institute (PCORI). Based on this award, some additional endpoints (e.g. neuromonitoring, patient and family experience) were added as secondary endpoints in this study. The core version of this study remained unchanged. There will be no industry funding of the SETPOINT 2 study. This is not an investigation of any specific medical products or medications.
- Tracheostomy Procedure
Intervention Desc: Tracheostomy is performed as percutaneous dilatative tracheostomy with tracheostomy kit by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied. ARM 1: Kind: Experimental Label: Early Tracheostomy Description: Patients randomized to early tracheostomy receive (preferably dilatative) tracheostomy within 5 days from intubation. Intervention: Procedure: Early Tracheostomy ARM 2: Kind: Experimental Label: Prolonged Intubation Description: Patients randomized to this arm will be tried to wean off the ventilator and get (an) extubation trial(s) if regarded feasible. In case of failure or non-feasibility, they receive tracheostomy after intubation day 10. Intervention: Procedure: Late Tracheostomy
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Functional outcome||6 months||No|
|Secondary||Hospital Length of stay||participants will be followed for the duration of hospital stay, an expected average of 3 weeks||No|
|Secondary||Duration of ventilation||participants will be followed for the duration of hospital stay, an expected average of 5 weeks||No|
|Secondary||Duration and Quality of Weaning||participants will be followed for the duration of weaning, an expected average of 6 weeks||No|
|Secondary||Time of Analgosedation Dependence||participants will be followed for the duration of hospital stay, an expected average of 3 weeks||No|
|Secondary||Time of ICU dependence||participants will be followed for the duration of hospital stay, an expected average of 3 weeks||No|
|Secondary||Vasopressor Dependence||participants will be followed for the duration of hospital stay, an expected average of 3 weeks||No|
|Secondary||Number and type of complications||10 days post tracheostomy||Yes|
|Secondary||Cost of treatment||participants will be followed for the duration of hospital stay, an expected average of 3 weeks||No|
|Secondary||Richmond Agitation Sedation Scale Score||participants will be followed for the duration of hospital stay, an expected average of 3 weeks|
|Secondary||Riker Sedation-Agitation-Score||participants will be followed for the duration of hospital stay, an expected average of 3 weeks|
|Secondary||Burden scale for Family caregivers BSFC-s||at discharge and after 6 month|
|Secondary||Patient reported outcome questions||after 6 month|