SETPOINT2 – Patients and Families2018-03-14T08:42:35+00:00

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.

What patients are eligible for SETPOINT2?

Patients may be considered eligible for SETPOINT2 if they have respiratory failure (cannot breathe) after a stroke or a spontaneous brain hemorrhage. Investigators will apply the SETScore, a tool designed to help identify patients likely to require a temporary tracheostomy. If the SETScore is high (above 10) and the senior doctor in charge of the patient agrees based on their clinical experience that the patient is likely to require a tracheostomy, then they may qualify to participate in the study. 

Setpoint 2

Why do some stroke patients have respiratory failure?

After a severe stroke, patients may lack airway protective reflexes to keep bacteria and secretions out of the lungs, and this “aspiration” may lead to breathing difficulty. Additionally, some strokes may affect the cough reflex, or the drive to breathe, or may prevent maintenance of a patient upper airway. If these conditions are severe, breathing may fail, and intubation (the placement of a breathing tube into the trachea, or windpipe) and mechanical ventilation may be necessary to keep the stroke patient alive. If the respiratory failure is prolonged, then tracheostomy is typically required.

What will happen if my family member decides to participate in the study?

If the patient is eligible for participation in SETPOINT2, and their legally authorized representative offers informed consent to participate in the study, then the patient is enrolled and randomized. Randomization means the patients is selected by the computer to receive either an early (before day 5) or delayed (only after day 10, if needed) tracheotomy. Once the randomization occurs, the treatment team will continue standard stroke care, and will either arrange an early tracheostomy or else continue to attempt ventilator weaning, including daily consideration of extubation. You will find out immediately after randomization whether the patient is to receive an early tracheostomy, or else tracheostomy on a delayed basis if necessary.

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