LandmarkRCT

SETPOINT2

Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation: The SETPOINT2 Randomized Clinical Trial.

JAMA, 2022 · Multicenter randomized trial

Population: 382 adults with severe stroke needing ventilation
Intervention: Early tracheostomy
Comparator: Standard timing strategy
Primary outcome: Six-month modified Rankin 0–4
Result: 43.5% versus 47.1%; adjusted OR 0.93 (95% CI 0.60–1.42).

What the trial found

43.5% versus 47.1%; adjusted OR 0.93 (95% CI 0.60–1.42).

Clinical interpretation

No significant functional benefit; stroke population and wide intervals limit extrapolation to every ICU subgroup.

Moderate certainty

Clinical Context & Relevant Topics (1)

Disease Reference

Tracheostomy & Difficult Ventilator Liberation

Systematic evaluation of failed liberation, tracheostomy timing/selection, cuff and secretion management, and multidisciplinary weaning.

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