Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Supplemental oxygen is fundamental in caring for critically ill trauma. While the avoidance of hypoxia is vital, the current clinical practice of excessive oxygenation settings is common, and unnecessary, and may even be harmful.
An expert panel convened to define optimal oxygenation targets in critically ill trauma patients. The strong consensus was to target normoxia at an oxygen saturation (SpO2) range of 90-96% and arterial oxygen (PaO2) range of 60-100 mmHg. Accordingly, a pilot trial implementation of this consensus will occur for the care of trauma patients.
Specific Aim:
This is an observational pre/post study to evaluate the impact of targeted normoxia implementation in optimizing oxygen delivery and oxygenation in critically ill trauma patients.
Hypotheses:
That the clinical efforts to improve adherence to oxygen guidelines will:
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improve the proportion of time spent with target normoxia thresholds (oxygen saturation SpO2 90-96%) by
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reducing utilization of unnecessary supplementation oxygen
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without a substantive increase in hypoxic episodes or an adverse impact on clinical outcomes.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pre-implementation The control groups will be trauma patients admitted to the ICU 12 months prior to targeted normoxia |
Other: Usual Care Oxygenation
The control (pre-implementation) group will be trauma patients admitted to the ICU during the 12 months prior to the targeted normoxia implementation
|
| Post-implementation The intervention group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation. |
Other: Targeted Normoxia (oxygen saturation 90-96%)
The intervention (post-implementation) group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation
|
Outcome Measures
Primary Outcome Measures
- Oxygen by volume [From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days]
Volume of oxygen administered during hospital stay
Secondary Outcome Measures
- Episodes of Hypoxia (SpO2< 88%) [From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days]
SpO2 saturations below 88%
- Episodes of Hyperoxia (SpO2 >96%) [From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days]
SpO2 saturations above 96%
- Ventilator Free Day [From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days]
Ventilator Free Days = Days off ventilator
- Time to room air [From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days]
Duration of supplemental oxygen
- Measured by daily Sequential Organ Failure Assessment (SOFA) [First 7 days of hospitalization]
Acute organ injury as measured by SOFA score
- ICU length of stay [From time of emergency department arrival until the date of ICU discharge or death, assessed up to 180 days]
Number of days spent in the ICU
- Hospital length of stay [From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days]
Number of days spent in the hospital
- Hospital discharge disposition [Date of hospital discharge, assessed up to 180 days]
Discharged to facility or home = measuring illness at discharge
- Hospital Mortality [From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Acute Injury/Trauma
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Arrival to Emergency Department
Exclusion Criteria:
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<18 years of age
-
Known prisoners
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
- United States Department of Defense
Investigators
- Principal Investigator: Adit Ginde, MD, MPH, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18-1528