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Completed

NCT Number: NCT03537937

Pragmatic Investigation of optimaL Oxygen Targets Trial

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.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Lower SpO2 Target

Other

SpO2 target 90% (range 88-92%)

Intermediate SpO2 Target

Other

SpO2 target 94% (range 92-96%)

Higher SpO2 Target

Other

SpO2 target 98% (range 96-100%)

Primary outcomes

  1. Ventilator-free Days (VFDs) to Study Day 28

    Time frame: 28 days

    Number of days alive and free from invasive mechanical ventilation between the final liberation from invasive mechanical ventilation before 28 days and study day 28. Patients who continue to receive invasive mechanical ventilation at day 28 or have died prior to day 28 will receive zero VFDs. For patients who return to invasive mechanical ventilation and are subsequently liberated from invasive mechanical ventilation prior to day 28, VFDs will be counted from final liberation from mechanical ventilation.

Secondary outcomes

  1. 28-day, In-hospital Mortality (Secondary Outcome)

    Time frame: 28 days

    All-cause mortality prior to discharge from the hospital, assessed at 28 days after enrollment (Secondary Outcome).

  2. Intensive Care Unit Mortality (Exploratory Clinical Outcome)

    Time frame: 28 days

    All-cause mortality prior to transfer out of the intensive care unit

  3. Vasopressor-free Days (Exploratory Clinical Outcome)

    Time frame: 28 days

    Number of days alive and free from vasopressor receipt between the final receipt of vasopressors before 28 days and study day 28.

  4. Renal Replacement Therapy-free Days (Exploratory Clinical Outcome)

    Time frame: 28 days

    Number of days alive and free from renal replacement therapy between the final receipt of renal replacement therapy before 28 days and study day 28

  5. Intensive Care Unit-free Days (Exploratory Clinical Outcome)

    Time frame: 28 days

    Number of days alive and free from intensive care unit admission after the final transfer out of the intensive care unit before 28 days to study day 28

  6. Hospital-free Days (Exploratory Clinical Outcome)

    Time frame: 28 days

    Number of days alive and free from hospital admission to study day 28

  7. Acute Kidney Injury (AKI) (Exploratory Organ Function Outcome)

    Time frame: 28 days

    Presence of Stage II or greater AKI by Kidney Disease: Improving Global Outcomes (KDIGO) criteria

Other outcomes

  1. Atrial Arrhythmia (Exploratory Safety Outcome)

    Time frame: 28 days

    Documented atrial arrhythmia

  2. Ventricular Arrhythmia (Exploratory Safety Outcome)

    Time frame: 28 days

    Documented ventricular arrhythmia

  3. Cardiac Arrest (Exploratory Safety Outcome)

    Time frame: 28 days

    Cardiac arrest with return of spontaneous circulation

  4. Pneumothorax or Pneumomediastinum (Exploratory Safety Outcome)

    Time frame: 28 days

    Pneumothorax or pneumomediastinum as defined by documentation in the electronic health record by treating clinicians or radiology of a pneumothorax on thoracic imaging or thoracic ultrasound.

  5. Ischemic Stroke (Exploratory Safety Outcome)

    Time frame: 28 days

    New ischemic stroke between enrollment and 28 days after enrollment as diagnosed by computed tomography, magnetic resonance imaging, or cerebral angiography.

  6. Myocardial Infarction (Exploratory Safety Outcome)

    Time frame: 28 days

    New myocardial infarction between enrollment and 28 days after enrollment, defined as detection of a rise in cardiac troponin values with at least one value above the 99th percentile and clinical evidence of acute myocardial ischemia.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Pragmatic Investigation of optimaL Oxygen Targets (PILOT) Trial

Acronym: PILOT

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 25, 2018
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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