CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 6,000 target
Drug / intervention
Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04534959
NCT04534959Phase 3ActiveUpdate OverdueUpdated 14mo ago · Completion was 43mo ago
Enrollment Stalled
CompareCT.gov

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

University of Colorado, Denver·interventional·Posted Sep 1, 2020·Updated Apr 2, 2025

In Brief

A Phase 3 clinical trial evaluating Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg) for Critical Illness and 3 related conditions. Active but no longer recruiting, targeting 6,000 participants across 8 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Illness, Wounds and Injury, Disease Attributes, Pathologic Processes
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

Phase 3ActiveOverdue
202120222023202420252026
First PostedSep 1, 2020
Enrollment StartOct 15, 2020
Primary CompletionNov 15, 2022
Study CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.8 years ago

Interventions

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).