Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients

NCT ID: NCT04534959

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 6000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2025-06-30

Brief 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.

Detailed 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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-Implementation

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Post-Implementation Targeting Normoxemia in Trauma ICU

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adit Ginde, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Alabama-Birmingham Medical Center

Birmingham, Alabama, United States

Denver Health

Denver, Colorado, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Oregon Health and Sciences University

Portland, Oregon, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, 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

Countries

United States

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Other Identifiers

19-2153

Identifier Type: -

Identifier Source: org_study_id