Results Summary

What was the research about?

After a severe stroke, some patients can’t breathe on their own. When this happens, patients may need a ventilator. A ventilator is a machine that pumps air into the lungs through a tube in the patient’s throat that leads to their windpipe. But over time, the tube can cause problems like throat ulcers.

To avoid these problems, doctors can perform a surgery called a tracheostomy. In this surgery, doctors place the tube directly in the windpipe, avoiding the throat. But questions remain about when to do this surgery among patients with severe stroke.

In this study, the research team wanted to learn if having this surgery early compared to the standard time improved patients’ physical condition and patient and family experiences of care. Early surgery was on or before the fifth day after patients went on a ventilator; standard timing was at least 10 days later.

What were the results?

After six months, patients who had early or standard timing of surgery didn’t differ in:

  • Physical disability, such as mobility and ability to care for themselves
  • Quality of life
  • Medicine use
  • Need for treatment for pressure around the brain
  • Length of time in a coma, on a ventilator, in the hospital, or in an intensive care unit, or ICU
  • Adverse events, like serious bleeding
  • Death or cause of death
  • Timing and reason for ending life support
  • Patient and family satisfaction with care

All patients had high disability; after six months:

  • 70 percent hadn’t returned to their usual activities or had severe problems doing so.
  • 60 percent couldn’t walk or had severe problems walking.
  • 55 percent couldn’t wash or dress themselves or had severe problems doing so.

Among caregivers, 49 percent reported severe or very severe burden; 43 percent had moderate burden.

Patients and family members felt satisfied with care.

Who was in the study?

The study included 382 patients with severe stroke. All received care at one of 25 ICUs in the United States and Germany. Of patients, 59 percent were White, 13 percent were Black or African American, 2 percent were of another race, and 26 percent had missing data on race; 6 percent were Hispanic. The average age was 58, and 50 percent were women.

What did the research team do?

The research team assigned patients by chance to have surgery early or at the standard time. The team interviewed patients and caregivers by phone about patient disability, caregiver burden, and satisfaction with care. The team also looked at health records.

Stroke survivors and caregivers, advocacy groups, clergy, and healthcare providers and administrators gave input on the study.

What were the limits of the study?

Only 25 percent of patients completed interviews, compared with 96 percent of caregivers.

Future research could use in-person staff who are trained to work with stroke survivors to ask patients about their experiences.

How can people use the results?

Doctors, patients, and caregivers can use the results when considering treatment to support breathing after severe stroke.

Final Research Report

This project's final research report is expected to be available by July 2024.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers questioned the generalizability of this study since it was performed at tertiary care settings focused on providing neurological, particularly stroke-related, services. Such settings were likely to provide more comprehensive and state-of-the-art stroke care than lower-income, rural and otherwise underfunded facilities. The researchers revised their description of the study’s generalizability to caution smaller facilities that the results of this study may not be applicable and that less resourced facilities should be careful in providing early tracheostomy interventions. The authors did state that given the low rate of adverse events in the early tracheostomy participant group, this treatment might be successful if their methods were followed.
  • The reviewers pointed out that there were discrepancies in outcomes reported by patients versus their surrogates, which can be problematic in studies where many patients would not be able to respond. Given the small number of stroke patients who could self-report their outcomes, the reviewers asked whether the reliance on surrogate reports would favor more aggressive treatment because of respondents’ desires to save their loved one. The researchers admitted that they had no answer to this concern other than to be transparent about the difficulties in getting self-reports from stroke patients and respect the data provided by family caregivers and other surrogates.
  • The reviewers asked the researchers to expand their presentation of secondary study results particularly for subgroup interactions. The researchers had also not included the planned hierarchical analyses according to the report. The researchers explained that since their primary analyses did not show group differences in stroke outcomes, they did not continue with secondary analyses.

Conflict of Interest Disclosures

Project Information

David B. 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
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Last updated: April 26, 2024