Clinical trial NCT03537937: Pragmatic Investigation of optimaL Oxygen Targets Trial
Official title: Pragmatic Investigation of optimaL Oxygen Targets (PILOT) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 2541
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In the PILOT trial, the entire study ICU will be assigned to a single SpO2 target (cluster-randomized) and the ICU will switch between lower, intermediate, and higher SpO2 targets every two months in a randomly generated sequence (cluster-crossover).
Primary purpose: TREATMENT

Brief summary: Mechanical ventilation of ICU patients universally involves titration of the fraction of inspired oxygen (FiO2) to maintain arterial oxygen saturation (SpO2). Despite decades of ICU practice, however, the optimal SpO2 target remains unknown. Current guidelines offer divergent recommendations as to the optimal SpO2 target. Therefore, we propose a 2,250-patient cluster-randomized cluster-crossover trial comparing a lower SpO2 target (90%; range 88-92%), an intermediate SpO2 target (94%; range 92-96%), and a higher SpO2 target (98%; range 96-100%) with regard to the outcome of days alive and free of invasive mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Receiving mechanical ventilation through an endotracheal tube or tracheostomy
3. Admitted to the study ICU or admission to the study ICU from the emergency department is planned

Exclusion Criteria:

1. Known pregnancy or beta hCG level greater than the laboratory upper limit of normal in a patient capable of becoming pregnant
2. Known to be a prisoner

Primary outcomes:
measure: Ventilator-free Days (VFDs) to Study Day 28
timeFrame: 28 days
Secondary outcomes:
measure: 28-day, In-hospital Mortality (Secondary Outcome)
timeFrame: 28 days
measure: Intensive Care Unit Mortality (Exploratory Clinical Outcome)
timeFrame: 28 days
measure: Vasopressor-free Days (Exploratory Clinical Outcome)
timeFrame: 28 days
measure: Renal Replacement Therapy-free Days (Exploratory Clinical Outcome)
timeFrame: 28 days
measure: Intensive Care Unit-free Days (Exploratory Clinical Outcome)
timeFrame: 28 days
measure: Hospital-free Days (Exploratory Clinical Outcome)
timeFrame: 28 days
measure: Acute Kidney Injury (AKI) (Exploratory Organ Function Outcome)
timeFrame: 28 days
Other outcomes:
measure: Atrial Arrhythmia (Exploratory Safety Outcome)
timeFrame: 28 days
measure: Ventricular Arrhythmia (Exploratory Safety Outcome)
timeFrame: 28 days
measure: Cardiac Arrest (Exploratory Safety Outcome)
timeFrame: 28 days
measure: Pneumothorax or Pneumomediastinum (Exploratory Safety Outcome)
timeFrame: 28 days
measure: Ischemic Stroke (Exploratory Safety Outcome)
timeFrame: 28 days
measure: Myocardial Infarction (Exploratory Safety Outcome)
timeFrame: 28 days
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Matthew W Semler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Semler MW, Casey JD, Lloyd BD, Hastings PG, Hays MA, Stollings JL, Buell KG, Brems JH, Qian ET, Seitz KP, Wang L, Lindsell CJ, Freundlich RE, Wanderer JP, Han JH, Bernard GR, Self WH, Rice TW; PILOT Investigators and the Pragmatic Critical Care Research Group. Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation. N Engl J Med. 2022 Nov 10;387(19):1759-1769. doi: 10.1056/NEJMoa2208415. Epub 2022 Oct 24.
citation: Semler MW, Casey JD, Lloyd BD, Hastings PG, Hays M, Roth M, Stollings J, Brems J, Buell KG, Wang L, Lindsell CJ, Freundlich RE, Wanderer JP, Bernard GR, Self WH, Rice TW; PILOT Investigators and the Pragmatic Critical Care Research Group. Protocol and statistical analysis plan for the Pragmatic Investigation of optimaL Oxygen Targets (PILOT) clinical trial. BMJ Open. 2021 Oct 28;11(10):e052013. doi: 10.1136/bmjopen-2021-052013.