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

University of Colorado Denver (CU Denver)

Status and phase: Active, not recruiting; Phase 3

Conditions: Disease Attributes; Critical Illness; Pathologic Processes; Wounds and Injury

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04534959

19-2153

Details and patient eligibility

About

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.

Full 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

Enrollment: 6,000 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6,000 participants in 2 patient groups

Pre-Implementation

No Intervention group

Description:

The control (pre-implementation) group will be trauma patients admitted to the surgical/trauma ICU during the site's control period of the stepped-wedge implementation process (up to 22 months).

Post-Implementation Targeting Normoxemia in Trauma ICU

Experimental group

Description:

The intervention (post-implementation) group will be patients admitted to the surgical/trauma ICU during the targeted normoxemia intervention period of the stepped-wedge implementation process (up to 25 months).

Treatment:

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