Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients

Critical Illness Clinical Trial

— SAVE-O2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04534959
• Other study ID #: 19-2153
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 15, 2020
• Est. completion date: February 15, 2025

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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: 1. 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] 2. Limit use of excessive supplemental oxygen 3. Reduce exposure to hyperoxemia without a substantive increase in hypoxemic episodes or adverse effects

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6000
• Est. completion date: February 15, 2025
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Disease Attributes
• Pathologic Processes
• Wounds and Injuries
• Wounds and Injury

Intervention

Other:
• Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)
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).

Locations

Country	Name	City	State
United States	University of Alabama-Birmingham Medical Center	Birmingham	Alabama
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Denver Health	Denver	Colorado
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health and Sciences University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (38)

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Helmerhorst HJ, Roos-Blom MJ, van Westerloo DJ, de Jonge E. Association Between Arterial Hyperoxia and Outcome in Subsets of Critical Illness: A Systematic Review, Meta-Analysis, and Meta-Regression of Cohort Studies. Crit Care Med. 2015 Jul;43(7):1508-19. doi: 10.1097/CCM.0000000000000998. — View Citation

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Helmerhorst HJ, Schultz MJ, van der Voort PH, Bosman RJ, Juffermans NP, de Wilde RB, van den Akker-van Marle ME, van Bodegom-Vos L, de Vries M, Eslami S, de Keizer NF, Abu-Hanna A, van Westerloo DJ, de Jonge E. Effectiveness and Clinical Outcomes of a Two-Step Implementation of Conservative Oxygenation Targets in Critically Ill Patients: A Before and After Trial. Crit Care Med. 2016 Mar;44(3):554-63. doi: 10.1097/CCM.0000000000001461. — View Citation

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ICU-ROX Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group; Mackle D, Bellomo R, Bailey M, Beasley R, Deane A, Eastwood G, Finfer S, Freebairn R, King V, Linke N, Litton E, McArthur C, McGuinness S, Panwar R, Young P; ICU-ROX Investigators the Australian and New Zealand Intensive Care Society Clinical Trials Group. Conservative Oxygen Therapy during Mechanical Ventilation in the ICU. N Engl J Med. 2020 Mar 12;382(11):989-998. doi: 10.1056/NEJMoa1903297. Epub 2019 Oct 14. — View Citation

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Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Hogdall C, Lundvall L, Svendsen PE, Mollerup H, Lunn TH, Simonsen I, Martinsen KR, Pulawska T, Bundgaard L, Bugge L, Hansen EG, Riber C, Gocht-Jensen P, Walker LR, Bendtsen A, Johansson G, Skovgaard N, Helto K, Poukinski A, Korshin A, Walli A, Bulut M, Carlsson PS, Rodt SA, Lundbech LB, Rask H, Buch N, Perdawid SK, Reza J, Jensen KV, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial. JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452. — View Citation

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Supplemental Oxygen Free Days (SOFD)	Number of days alive and not on supplemental oxygen during the index hospitalization (0 days [worst outcome] to 28 days [best outcome])	up to 28 days
Secondary	Hospital-Free Days to day 90 (HFD90)	Number of days alive and outside the hospital (0 days [worst outcome] to 90 days [best outcome])	up to 90 days
Secondary	In-hospital Mortality to day 90	Dichotomous vital status (survived or died) at hospital discharge or day 90, whichever is first	up to 90 days
Secondary	Time to Mortality to day 90	Vital status and date of death censored at hospital discharge or day 90, whichever is first	up to 90 days
Secondary	Ventilator Free Day (VFD) to day 28	Ventilator Free Days = Days off ventilator (0 VFD [worst outcome] to 28 VFD [best outcome])	up to 28 days
Secondary	Time to Room Air	Duration of supplemental oxygen (FiO2 = 0.21 or room air)	up to 90 days
Secondary	Glasgow Outcome Score (GOS)	Patient will be assessed at hospital discharge with one of the following five categories: Death, Persistent Vegetative State, Severe Disability, Moderate Disability, Low Disability	up to 90 days
Secondary	Discharge Disposition	Defined as home (return to prior level of care) or facility (e.g., acute rehab, skilled nursing facility)	up to 90 days
Secondary	Amount of Supplemental Oxygen Administered	Total estimated oxygen volume while in the ICU after hospital arrival	up to 90 days
Secondary	Duration of Time on Normoxemia Protocol Target	Defined as SpO2 90-96% or receiving no supplemental oxygen (FiO2 0.21 or room air) while in the ICU	up to 90 days
Secondary	Proportion of Participants Receiving High Levels of Supplemental Oxygen	FiO2>0.40 or >4 liters per minute for >2 hours while in the ICU [excludes time in the operating room]	up to 90 days
Secondary	Duration of Time receiving High Levels of Supplemental Oxygen	FiO2>0.40 or >4 liters per minute while in the ICU	up to 90 days
Secondary	Duration of Time Receiving No Supplemental Oxygen	FiO2 0.21 or room air while in the ICU	up to 90 days
Secondary	Incidence of Hypoxemic Event (SpO2<88%)	SpO2 saturation below 88% while in the ICU	up to 28 days
Secondary	Duration of Hypoxemic Events (SpO2<88%)	SpO2 saturation below 88% while in the ICU	up to 90 days
Secondary	incidence of Hyperoxemic Event (SpO2>96%)	SpO2 saturation above 96% while in the ICU	up to 90 days
Secondary	Duration of Hyperoxemic Event (SpO2>96%)	SpO2 saturation above 96% while in the ICU	up to 90 days