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Active, Not Recruiting

NCT Number: NCT04534959

Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients

The objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in critically injured patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Critical Illness Burns Disease Attributes Hyperoxia Hypoxia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Wounds and Injuries Wounds and Injury

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama-Birmingham Medical Center, Birmingham, Alabama, United States

Loading trial locations.

About this study

Oxygen therapy has undisputed importance in the care of critically ill patients to prevent secondary complications related to hypoxemia. Although routine, the practice of excessive over-oxygenation may be harmful. An expert panel was convened and developed the strong consensus to target normoxemia at an oxygen saturation (SpO2) range of 90-96%, an arterial oxygen (PaO2) range of 60-100 mmHg (when applicable), and a fraction of inspired oxygen (FiO2) of 21% for mechanically ventilated patients or room air for nonmechanically ventilated patients.

Specific Aim: The purpose of this study is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in critically injured patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.

Hypotheses: Clinical efforts to through a multimodal educational intervention will:

  • Improve the proportion of time spent within target normoxemia thresholds (oxygen saturation [SpO2] 90-96% and/or arterial oxygen [PaO2] 60-100 mmHg [when applicable]
  • Limit use of excessive supplemental oxygen
  • Reduce exposure to hyperoxemia without a substantive increase in hypoxemic episodes or adverse effects

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acutely injured patients who meet the criteria for entry into the state or national trauma registry
  • Admission to surgical/trauma ICU within 24 hours of hospital arrival

Exclusion criteria

  • Age <18 years
  • Prisoners
  • Known pregnancy
  • Transferred patients not admitted through the emergency department

Treatment and study plan

Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)

Other

Post-implementation of targeted normoxemia through oxygen titration for individual patients. Interventions for treatment of hypoxemia will follow usual local practice. Interventions for treatment of hyperoxemia (SpO2 >96% or PaO2 >100 mmHg) will involve down titration of FiO2 (or supplemental oxygen for non-mechanically ventilated patients) within a time frame based on local site preferences-typically in increments of no greater than 0.10 until goal oxygenation in the normoxemia range is achieved (including room air [no supplemental oxygen] for non-mechanically ventilated patients).

Primary outcomes

  1. Supplemental Oxygen Free Days (SOFD)

    Time frame: up to 28 days

    Number of days alive and not on supplemental oxygen during the index hospitalization (0 days [worst outcome] to 28 days [best outcome])

Secondary outcomes

  1. Hospital-Free Days to day 90 (HFD90)

    Time frame: up to 90 days

    Number of days alive and outside the hospital (0 days [worst outcome] to 90 days [best outcome])

  2. In-hospital Mortality to day 90

    Time frame: up to 90 days

    Dichotomous vital status (survived or died) at hospital discharge or day 90, whichever is first

  3. Time to Mortality to day 90

    Time frame: up to 90 days

    Vital status and date of death censored at hospital discharge or day 90, whichever is first

  4. Ventilator Free Day (VFD) to day 28

    Time frame: up to 28 days

    Ventilator Free Days = Days off ventilator (0 VFD [worst outcome] to 28 VFD [best outcome])

  5. Time to Room Air

    Time frame: up to 90 days

    Duration of supplemental oxygen (FiO2 = 0.21 or room air)

  6. Glasgow Outcome Score (GOS)

    Time frame: up to 90 days

    Patient will be assessed at hospital discharge with one of the following five categories: Death, Persistent Vegetative State, Severe Disability, Moderate Disability, Low Disability

  7. Discharge Disposition

    Time frame: up to 90 days

    Defined as home (return to prior level of care) or facility (e.g., acute rehab, skilled nursing facility)

  8. Amount of Supplemental Oxygen Administered

    Time frame: up to 90 days

    Total estimated oxygen volume while in the ICU after hospital arrival

  9. Duration of Time on Normoxemia Protocol Target

    Time frame: up to 90 days

    Defined as SpO2 90-96% or receiving no supplemental oxygen (FiO2 0.21 or room air) while in the ICU

  10. Proportion of Participants Receiving High Levels of Supplemental Oxygen

    Time frame: up to 90 days

    FiO2>0.40 or >4 liters per minute for >2 hours while in the ICU [excludes time in the operating room]

  11. Duration of Time receiving High Levels of Supplemental Oxygen

    Time frame: up to 90 days

    FiO2>0.40 or >4 liters per minute while in the ICU

  12. Duration of Time Receiving No Supplemental Oxygen

    Time frame: up to 90 days

    FiO2 0.21 or room air while in the ICU

  13. Incidence of Hypoxemic Event (SpO2<88%)

    Time frame: up to 28 days

    SpO2 saturation below 88% while in the ICU

  14. Duration of Hypoxemic Events (SpO2<88%)

    Time frame: up to 90 days

    SpO2 saturation below 88% while in the ICU

  15. incidence of Hyperoxemic Event (SpO2>96%)

    Time frame: up to 90 days

    SpO2 saturation above 96% while in the ICU

  16. Duration of Hyperoxemic Event (SpO2>96%)

    Time frame: up to 90 days

    SpO2 saturation above 96% while in the ICU

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients (SAVE-O2)

Acronym: SAVE-O2

Important dates

Study start
2020
Primary completion
2022
Study completion
2025
First posted
Sep 1, 2020
Registry last updated
Apr 2, 2025

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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