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Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients

NCT04534959 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2025-04-02

No results posted yet for this study

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.

Conditions

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

Interventions

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).

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Adit Ginde, MD, MPH · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2022-11-15
Completion
2025-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04534959 on ClinicalTrials.gov