Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final. In the meantime, results have been published in peer-reviewed journals, as listed below.

What is the research about?

Some patients who have had a severe stroke can’t breathe on their own. When this happens, doctors put a breathing tube in the patient’s windpipe, and a machine pumps air into the lungs. But having a breathing tube for a long time can be uncomfortable for patients and can cause problems such as throat ulcers. Doctors sometimes perform a tracheostomy, or surgery to open an airway to the windpipe. Most often, patients have this surgery one to two weeks after the stroke.

Researchers don’t know the best time to do a tracheostomy in patients with severe stroke and breathing failure. Research suggests that having this surgery sooner may help patients. Earlier surgery may mean that patients can breathe on their own sooner without a breathing tube and go home sooner. It may also be safer, possibly leading to fewer deaths and illnesses such as pneumonia.

In this study, the research team wants to know if patients who have early tracheostomy have better survival and recovery compared with patients who have the surgery later.

Who can this research help?

Results from this study can guide doctors, patients, and caregivers facing decisions about treatment following severe stroke and breathing failure.

What is the research team doing?

The research team is recruiting 380 patients who have had a severe stroke and are in 1 of 20 intensive care units, or ICUs, in the United States and Germany. Patients are eligible for the study if a doctor predicts that the patient will need a breathing tube and ventilation machine for two weeks or more. The team is assigning patients to one of two groups by chance. Patients in the first group have an early tracheostomy, on or before the fifth day after doctors place a breathing tube in their windpipe. Patients in the second group have a delayed tracheostomy, after day 10. Doctors check often to see if they can safely remove the breathing tube and let patients breathe on their own.

During the hospital stay, the research team is measuring 

  • Complications from surgery
  • How many days patients need the breathing machine
  • How well patients wean off the breathing machine
  • How many days patients need to take medicines for pain, sedation, or to constrict blood vessels
  • How agitated or sedated patients are
  • How many days patients spend in a coma
  • Patients’ quality of life
  • How satisfied patients and families are with care
  • Length of hospital stay

Six months after admission to the hospital, the research team is looking to see how many patients survived. The team is also measuring patients’ disability in daily activities and how much burden caregivers report. The team is comparing all outcomes between the two groups.

Stroke survivors and family members from the United States and Germany, clinicians and caregivers, advocacy groups, clergy, hospital administrators, and stroke specialists helped design the study, choose outcomes, and plan the informed consent process. 

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population 380 adult patients with severe acute ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage admitted to ICUs in the United States and Germany predicted to need prolonged (14 days or more) mechanical ventilation
  • Early tracheostomy (on or before day 5 of hospital admission)
  • Delayed tracheostomy (after day 10)

Primary: disability

Secondary: tracheostomy-related adverse events, coma-free days, functional outcome, ventilator-free days, ICU-free days, length of hospital stay, sedative use, vasopressor use, antibiotic use, frequency of treatment for intracranial hypertension, timing and reason for withdrawal of life support measures, quality of life, mortality, cause of death, patient and family satisfaction with care

Timeframe Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 6-month follow-up for primary outcome

Project Information

David Seder, MD
Julian Bösel, MD
Maine Medical Center
SETPOINT 2: A Pragmatic Trial to Test the Effectiveness of Early vs. Delayed Percutaneous Tracheostomy in Patients with Severe Stroke and Respiratory Failure

Key Dates

December 2016
March 2023

Study Registration Information


Has Results
Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: November 30, 2022