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SETPOINT2: a pragmatic trial to test the effectiveness of early vs. delayed percutaneous tracheostomy in patients with severe stroke and respiratory failure
Investigator (PI): Seder, David; Bosel, Julian
Performing Organization (PO): (Current): Maine Medical Center / (207) 661-7001
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2017
Final Year: 2021
Record Source/Award ID: PCORI/CER-1602-34137
Funding: Total Award Amount: $2,563,349
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Outcomes: This trial will test whether tracheostomy (a more comfortable, temporary surgical airway) in stroke patients who require mechanical ventilation can be performed earlier than is customary, in order to improve survival and recovery. Background: Several studies suggest that when patients whose breathing has failed after a severe stroke undergo temporary tracheostomy within three to five days, the risks of pneumonia, prolonged hospital stay, deep sedation, and death are lower than when tracheostomy is performed on a delayed basis after 10 days. But a more rigorous study with a larger patient sample is now needed to determine definitively whether early tracheostomy is truly beneficial. Patients and family members participated in the pilot study and other stroke survivors have contributed to the design of this larger trial, which emphasizes both medical outcomes and the family experience. Procedure: In SETPOINT2, patients who have chosen to participate are assigned randomly either to undergo an early tracheostomy (on or before day five of admission to a hospital) or a delayed tracheostomy (after day 10) with ongoing attempts to wean them from the ventilator and take out the breathing tube. Patients with severe acute ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage who are admitted to intensive care will be invited to participate in this trial if they are predicted to need prolonged (10-14 days or more) of mechanical ventilation. Most of these patients would undergo a tracheostomy anyway; the experiment only changes the timing of the procedure. The primary outcome is the percentage of patients achieving a good outcome. Outcome is based on the modified Rankin scale, which is a widely used measure of disability after stroke. A Rankin score of 0 to 4 will be considered a good outcome, while 5 to 6 is a poor outcome. We will also look at other outcomes: tracheostomy-related adverse events such as bleeding, injury, or infection; how long patients stay in a coma (measured in days); how many days they need help breathing with a machine; how long they need sedatives and other medications; assessments of their quality of life after six months; and whether they survive. Patient-centeredness: In the United States and Germany, stroke survivors and family members participated in the study design and will provide ongoing feedback during the trial as members of a SETPOINT2 research advisory committee. Specifically, patient and family input into the primary study outcome (a Rankin score at six months) was crucial to design the most important aspect of the study. Also, family concerns about being "rushed" into a decision about research participation influenced our decision to allow up to four days before family members needed to give their informed consent. Their desire to see patients emerging sooner from a coma state influenced us to add a secondary outcome of "coma free days."
MeSH Terms:
  • Brain Ischemia /pathology
  • Cerebral Hemorrhage /pathology
  • Coma /prevention & control
  • Critical Care
  • Deep Sedation
  • Germany
  • Humans
  • Length of Stay
  • Outcome Assessment (Health Care)
  • Patient-Centered Care
  • Pilot Projects
  • Pneumonia /diagnosis
  • Pragmatic Clinical Trials as Topic
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Respiration, Artificial
  • Respiratory Insufficiency /*therapy
  • Stroke /*therapy
  • Stroke Rehabilitation
  • Subarachnoid Hemorrhage /pathology
  • Time Factors
  • Time-to-Treatment
  • Tracheostomy /*methods
  • Treatment Outcome
  • United States
Country: United States
State: Maine
Zip Code: 04101
UI: 20181532
CTgovId: NCT02377167
Project Status: Ongoing
Record History: ('2019: Project extended to 2021.',)