Preliminary Investigation of optimaL Oxygen Targets Trial

  • STATUS
    Recruiting
  • End date
    Jul 31, 2021
  • participants needed
    2250
  • sponsor
    Vanderbilt University Medical Center
Updated on 24 January 2021
mechanical ventilation
FIO2
oximetry
assisted ventilation

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.

Details
Condition Respiratory Failure
Treatment Lower SpO2 Target, Intermediate SpO2 Target, Higher SpO2 Target
Clinical Study IdentifierNCT03537937
SponsorVanderbilt University Medical Center
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Respiratory Failure?
Do you have any of these conditions: Do you have Respiratory Failure??
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
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