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.

Learn more about the SETPOINT2 research study process from the video below.

What is SETPOINT2?

SETPOINT2 is research study being done to look at the best timing for placing a tracheostomy after a severe stroke. 

Who can participate?

The study may be a good fit for your loved one if:

· he/she is in need of a breathing tube after a stroke

· the doctor caring for your loved one thinks he/she will need a tracheostomy

Please talk with your loved one’s doctor to see if SETPOINT2 is a good fit for him/her.

What is involved?

All participants are randomly assigned to one of two groups. Your loved one will have an equal chance of being placed in either group.

• Participants in the first group will receive a tracheostomy as soon as possible and within 5 days of needing a breathing tube.

• Participants in the second group will receive a tracheostomy 10 days or more after needing a breathing tube, if they cannot be safely weaned from the breathing machine.

Both groups will receive standard care treatment and a 6-month follow-up phone call. This phone call will allow the study team to check in on your loved one’s progress and recovery from stroke.

The only difference between the two groups is the timing of the tracheostomy.

Did you know?

A tracheostomy is a temporary breathing tube that enters the airway through the front of the neck and connects to a breathing machine.

 A tracheostomy takes the place of a breathing tube that goes through the mouth.

 The timing of this common procedure may affect how the brain recovers, and the body’s ability to return to pre-stroke activities.

 Some stroke patients have difficulty breathing because after a severe stroke, they may lack airway reflexes to keep bacteria and secretions out of the lungs, and this may lead to breathing difficulty. If these conditions are severe, breathing may fail, and the placement of a breathing tube into the trachea (or windpipe) and mechanical ventilation may be needed to keep the stroke patient alive. If the breathing failure continues, then a tracheostomy is typically required.

Questions?

If you have additional questions about the SETPOINT2 study or want to learn more about the study, please email our research study team at:  setpoint@mainehealth.org

 

Resources

Find a Stroke Support Group Near You
Stroke support groups challenge people to get beyond their limitations. Social interaction and simply feeling connected to others helps ease the depression and isolation so common after stroke. The American Heart Association has a great on-line tool,
go to: https://supportnetwork.heart.org/ OR  call 1-888-478-7653

Neurocritical Care Society
Search for a variety of intensive care management topics specifically for patients and families:  NCS

Clinical Trials
The National Institutes of Health (NIH) website is an international based website and has additional resources such as personal stories from participants and doctors, and a glossary of common terms used in clinical research.  Learn more at:  NIH

NIH – Health Topics
You can search a variety of health topics, including ventilator, tracheostomy, intubation here:  NIH – Health-topics

Research reported in this website was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (CER-1602-34137).