N/A
N=572
Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients
Trauma · Critical Illness · Oxygen Toxicity
Bottom Line
View on ClinicalTrials.gov: NCT03789396 ↗Enrolled (actual)
572
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Patient-time Hyperoxic and Not on Room Air — 40.6; 33.9 Percent patient-time in hyperoxia — p=0.03
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Targeted Normoxia (oxygen saturation 90-96%) (Other); Usual Care Oxygenation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient-time Hyperoxic and Not on Room Air |
40.6; 33.9 | 0.03 sig |
| SECONDARY Episodes of Hypoxia (SpO2< 88%) |
12; 14 | — |
| SECONDARY Episodes of Hyperoxia (SpO2 >96%) |
3151; 3037 | — |
| SECONDARY Ventilator Free Day |
28; 28 | — |
| SECONDARY Time to Room Air |
2; 2 | — |
| SECONDARY Measured by Daily Sequential Organ Failure Assessment (SOFA) |
— | — |
| SECONDARY ICU Length of Stay |
10.9; 10.4 | — |
| SECONDARY Hospital Length of Stay |
6; 7 | — |
| SECONDARY Hospital Discharge Disposition |
71.4; 71.1 | — |
| SECONDARY Hospital Mortality |
21; 16 | — |
Summary
The objective of this study is to conduct an observational pre/post study to evaluate the clinical impact oxygen guideline implementation on oxygen utilization and oxygenation in critically ill trauma patients.
Eligibility Criteria
Inclusion Criteria
- Acute Injury/Trauma
- Arrival to Emergency Department
Exclusion Criteria
- <18 years of age
- Known prisoners
Data sourced from ClinicalTrials.gov (NCT03789396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.