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The PILOT Trial

The PILOT Trial


October 24, 2022

Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation

Mazen Kherallah

Summarized by: 

What was the research question?

  • Does the clinical outcome in terms of ventilator-free days differ among different oxygen-saturation targets in patients on mechanical ventilation?

How did they do it?

  • A pragmatic, unblinded, cluster-randomized, cluster-crossover trial in the emergency department and medical intensive care unit at Vanderbilt University Medical Center in the US.

  • 2541 adult patients who were receiving mechanical ventilation were randomized to receive a lower target for oxygen saturation (90%; goal range, 88 to 92%), an intermediate target (94%; goal range, 92 to 96%), or a higher target (98%; goal range, 96 to 100%).

  • The primary outcome was ventilator-free days through day 28. The secondary outcome was death by day 28.

What did they find?

  • There was no significant difference in the median number of ventilator-free days between the lower-target group, intermediate-target group, and higher-target group (20 vs. 21 vs. 21 days, p=0.81).

  • In-hospital death by day 28 was not significantly different among the three groups (34.8% in the low-target, 34% in the intermediate target, and 33.2% in the high-target group).

  • There was no significant difference in the incidences of cardiac arrest, arrhythmia, myocardial infarction, stroke, and pneumothorax between the three groups.

Are there any limitations?

  • A single center study and study results may not be generalizable to other patient population.

  • Patient population was restricted to medical patients

  • The study neither confirms nor refutes treatment effects of a magnitude that is plausible

  • The study is unable to confirm or refute a heterogeneity of treatment effect.

What does it mean?

  • There was no difference in the number of ventilator-free days among critically ill adults receiving invasive mechanical ventilation when a lower, intermediate, or higher Spo2 target was used. Additionally, there were no differences in the secondary outcomes including 28-day mortality.

  • The study assures that the is no overt harm from liberal or restrictive oxygen regimen.

  • No change in clinical practice.


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