Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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: improve the proportion of time spent with target normoxia thresholds (oxygen saturation SpO2 90-96%) by reducing utilization of unnecessary supplementation oxygen without a substantive increase in hypoxic episodes or an adverse impact on clinical outcomes.

Official Title
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Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

Conditions
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Trauma, Critical Illness, Oxygen Toxicity

Intervention / Treatment
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* Other: Targeted Normoxia (oxygen saturation 90-96%)
* Other: Usual Care Oxygenation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute Injury/Trauma Arrival to Emergency Department Exclusion Criteria: <18 years of age Known prisoners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 109 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-implementation<br>The control groups will be trauma patients admitted to the ICU 12 months prior to targeted normoxia | Other: Usual Care Oxygenation<br>* The control (pre-implementation) group will be trauma patients admitted to the ICU during the 12 months prior to the targeted normoxia implementation<br>|
| Post-implementation<br>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%)<br>* The intervention (post-implementation) group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen by volume | Volume of oxygen administered during hospital stay | From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodes of Hypoxia (SpO2< 88%) | SpO2 saturations below 88% | From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days | 
| Episodes of Hyperoxia (SpO2 >96%) | SpO2 saturations above 96% | From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days | 
| Ventilator Free Day | Ventilator Free Days = Days off ventilator | From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days | 
| Time to room air | Duration of supplemental oxygen | From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days | 
| Measured by daily Sequential Organ Failure Assessment (SOFA) | Acute organ injury as measured by SOFA score | First 7 days of hospitalization | 
| ICU length of stay | Number of days spent in the ICU | From time of emergency department arrival until the date of ICU discharge or death, assessed up to 180 days | 
| Hospital length of stay | Number of days spent in the hospital | From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days | 
| Hospital discharge disposition | Discharged to facility or home = measuring illness at discharge | Date of hospital discharge, assessed up to 180 days | 
| Hospital Mortality |  | From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygenation, Hypoxia, Normoxia, Hyperoxia, Trauma, Critical Illness