Pragmatic Investigation of optimaL Oxygen Targets Trial

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Other: Lower SpO2 Target; Other: Intermediate SpO2 Target; Other: Higher SpO2 Target

• Registration Number: NCT03537937
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-25
• Study Start: 2018-07-01
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-11
• Results First Submitted: 2022-11-11
• Results First Submitted QC: 2022-11-11
• Last Update Submitted: 2022-11-11
• Results First Posted: 2023-09-25
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2541

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lower SpO2 Target	Lower SpO2 Target	During invasive mechanical ventilation in a study location, the fraction of inspired oxygen will be titrated to target an arterial oxygen saturation of 90% (range 88-92%).
Intermediate SpO2 Target	Intermediate SpO2 Target	During invasive mechanical ventilation in a study location, the fraction of inspired oxygen will be titrated to target an arterial oxygen saturation of 94% (range 92-96%).
Higher SpO2 Target	Higher SpO2 Target	During invasive mechanical ventilation in a study location, the fraction of inspired oxygen will be titrated to target an arterial oxygen saturation of 98% (range 96-100%).

Primary Outcome Measures

Name	Time	Method
Ventilator-free Days (VFDs) to Study Day 28	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 Outcome Measures

Name	Time	Method
Vasopressor-free Days (Exploratory Clinical Outcome)	28 days	Number of days alive and free from vasopressor receipt between the final receipt of vasopressors before 28 days and study day 28.
28-day, In-hospital Mortality (Secondary Outcome)	28 days	All-cause mortality prior to discharge from the hospital, assessed at 28 days after enrollment (Secondary Outcome).
Renal Replacement Therapy-free Days (Exploratory Clinical Outcome)	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
Hospital-free Days (Exploratory Clinical Outcome)	28 days	Number of days alive and free from hospital admission to study day 28
Acute Kidney Injury (AKI) (Exploratory Organ Function Outcome)	28 days	Presence of Stage II or greater AKI by Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Intensive Care Unit Mortality (Exploratory Clinical Outcome)	28 days	All-cause mortality prior to transfer out of the intensive care unit
Intensive Care Unit-free Days (Exploratory Clinical Outcome)	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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States