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. 2019 Nov 27;2019(11):CD012631. doi: 10.1002/14651858.CD012631.pub2

NCT03287466.

Trial name or title A randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients (TOXYC)
Methods RCT
Participants Mechanically ventilated adults
Interventions Experimental: SpO2 88% to 92%
The intervention is TO2T to achieve an arterial haemoglobin oxygen saturation (SpO2) of 88% to 92%.
Active comparator: SpO2 96% or above
The control group will also receive TO2T, but to achieve an SpO2 of 96% or above (standard care).
Outcomes Primary outcome measures

  1. Feasibility (time frame: 15 months)


Secondary outcomes

  1. Measurement of ABG (time frame: up to 21 days)

  2. Measurement of oxygen saturation (time frame: up to 21 days)

  3. Measurement of fraction of inspired oxygen (time frame: up to 21 days)

  4. Time to extubation or detachment from mechanical ventilation (time frame: up to 21 days)

  5. Mechanical ventilation‐free days on ICU (time frame: up to 21 days)

  6. Measurement of blood pressure (time frame: up to 21 days)

  7. Measurement of heart rate (time frame: up to 21 days)

  8. Measurement of cardiac rhythm (time frame: up to 21 days)

  9. Measurement of cardiac output and stroke volume (if measured) (time frame: up to 21 days)

  10. Measurement of vasopressor doses (time frame: up to 21 days)

  11. Measurement of inotrope doses (time frame: up to 21 days)

  12. Measurement of daily fluid balance (time frame: up to 21 days)

  13. Measurement of inotrope‐free days on ICU (time frame: up to 21 days)

  14. Measurement of vasopressor‐free days on ICU (time frame: up to 21 days)

  15. Measurement of urea (time frame: up to 21 days)

  16. Measurement of creatinine (time frame: up to 21 days)

  17. Measurement of urine output (time frame: up to 21 days)

  18. Need for renal replacement therapy (time frame: up to 21 days)

  19. Renal replacement therapy‐free days on ICU (time frame: up to 21 days)

  20. Measurement of transaminases (time frame: up to 21 days)

  21. Measurement of blood clotting values (time frame: up to 21 days)

  22. Measurement of bilirubin (time frame: up to 21 days)

  23. Measurement of blood lactate (time frame: up to 21 days)

  24. Measurement of troponin (time frame: up to 21 days)

  25. Adverse events (time frame: 90 days)

  26. SOFA score change (time frame: up to 21 days)

  27. APACHE II score change (time frame: up to 21 days)

  28. Length of ICU stay (time frame: up to 21 days)

  29. Length of hospital stay (time frame: 90 days)

  30. Mortality rates (time frame: 90 days)

  31. Days alive out of hospital (time frame: 90 days)
Starting date January 2018
Contact information Dr Jack D Grierson
Notes  

ABG: arterial blood gases; APACHE: Acute Physiology, Age, Chronic Health Evaluation; ARDS: acute respiratory distress syndrome; CO: conservative oxygenation; CPC: cerebral performance category; eGFR: estimated glomerular filtration rate; EQ‐5D‐5L: an instrument for measuring quality of life; FiO2: fraction of inspired oxygen; ICU: intensive care unit; LVEF: left ventricular ejection fraction; LO: liberal oxygenation; MAP: mean arterial pressure; MOCA: Montreal Cognitive Assessment; NT‐pro‐BNP: cardiac biomarker; OHCA: out‐of‐hospital cardiac arrest; PaO2: partial pressure of arterial oxygen; RBANS: Repeatable Battery for the Assessment of Neuropsychological Status; RCT: randomized controlled trial; SaO2: arterial oxygen saturation of haemoglobin; SIRS: systemic inflammatory response syndrome; SOFA: sequential organ failure assessment; SpO2: peripheral oxygen saturation; TO2T: targeted oxygen therapy