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Early Tracheostomy in Ventilated Stroke Patients 2 (SETPOINT2)

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ClinicalTrials.gov Identifier: NCT02377167
Recruitment Status : Recruiting
First Posted : March 3, 2015
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Maine Medical Center
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Julian Boesel, University Hospital Heidelberg

Brief 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.

Condition or disease Intervention/treatment Phase
Ischemic and Hemorrhagic Stroke, Subarachnoid Hemorrhage Procedure: Tracheostomy Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stroke-Related Early Tracheostomy Versus Prolonged Orotracheal Intubation in Neurocritical Care Trial 2
Study Start Date : May 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: Early Tracheostomy

Patients randomized to early tracheostomy receive (preferably dilatative) tracheostomy within 5 days from intubation.

Intervention: Procedure: Early Tracheostomy

Procedure: Tracheostomy
Tracheostomy is performed as percutaneous dilatative tracheostomy with tracheostomy kit by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.

Active Comparator: Prolonged Intubation

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

Procedure: Tracheostomy
Tracheostomy is performed as percutaneous dilatative tracheostomy with tracheostomy kit by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.




Primary Outcome Measures :
  1. Functional outcome [ Time Frame: 6 months ]
    Dichotomized functional outcome (a modified Rankin Scale (mRS) score of 0-4 (favorable outcome) vs 5,6 (poor outcome)) at 6 months after admission to ICU


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 6 months ]
    This secondary endpoint is assessed as time and type of death during the ICU-stay and 6 months after admission.

  2. Hospital Length of stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
    This secondary endpoint is assessed as days spent at the recruiting hospital from admission to discharge.

  3. Duration of ventilation [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]
    This secondary endpoint is assessed as half-days on the ventilator until the patient is ventilator-independent for 24 h.

  4. Duration and Quality of Weaning [ Time Frame: participants will be followed for the duration of weaning, an expected average of 6 weeks ]
    This secondary endpoint is assessed as half-days spent under the possible application of a weaning protocol, and spent within specific phases of such a protocol.

  5. Time of Analgosedation Dependence [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
    This secondary endpoint is assessed as half-days requiring the application of sedatives and analgesics which are also specified.

  6. Time of ICU dependence [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
    This secondary endpoint is assessed as days from admission to a pre-defined status that would allow discharge from ICU (absence of active infection, vasopressors, pulmonary and cardial instability etc.)

  7. Vasopressor Dependence [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
    This secondary endpoint is assessed as half-days spent under vasopressors during ICU-stay

  8. Number and type of complications [ Time Frame: 10 days post tracheostomy ]
    This secondary endpoint is assessed as the number and types of complications arelated to tracheostomy (i.e. bleeding, mispositioning, malfunction, replacement demand,etc.).

  9. Functional Outcome [ Time Frame: admission and discharge ]
    This secondary endpoint is assessed as the modified Rankin Scale (mRS) at the above named timepoints.

  10. Richmond Agitation Sedation Scale Score [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
    evaluation of consciousness and sedation score

  11. Riker Sedation-Agitation-Score [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
    evaluation of consciousness and sedation score

  12. Burden scale for Family caregivers BSFC-s [ Time Frame: at discharge and after 6 month ]
    assessment of the caregiver burden at the time of discharge from the NCCU and after 6 months

  13. Patient reported outcome questions [ Time Frame: after 6 month ]
    assessment of the patient and caregiver burden after 6 month



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377167


Contacts
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Contact: Silvia Schönenberger, Dr. 0049/62215637549 silvia.schoenenberger@med.uni-heidelberg.de

Locations
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Germany
UHHeidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Silvia Schönenberger, Dr.    0049/6221/5637549    silvia.schoenenberger@med.uni-heidelberg.de   
Contact: Julian Bösel, Dr.    0049/561/9804051    julian.boesel@klinikum-kassel.de   
Sponsors and Collaborators
University Hospital Heidelberg
Maine Medical Center
Patient-Centered Outcomes Research Institute

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julian Boesel, Prof. Dr. Julian Bösel, MD, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT02377167     History of Changes
Other Study ID Numbers: SETPOINT2
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Subarachnoid Hemorrhage
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages