Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Trauma
- Sponsor
- University of Colorado, Denver
- Enrollment
- 572
- Locations
- 1
- Primary Endpoint
- Patient-time Hyperoxic and Not on Room Air
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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: 1. improve the proportion of time spent with target normoxia thresholds (oxygen saturation SpO2 90-96%) by 2. reducing utilization of unnecessary supplementation oxygen 3. without a substantive increase in hypoxic episodes or an adverse impact on clinical outcomes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Acute Injury/Trauma
- •Arrival to Emergency Department
Exclusion Criteria
- •\<18 years of age
- •Known prisoners
Outcomes
Primary Outcomes
Patient-time Hyperoxic and Not on Room Air
Time Frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days from dates Jan. 1, 2018 to July 1, 2019
Total percentage of patient-time hyperoxic and not on room air: total time spent by patients in a hyperoxic state while receiving supplemental oxygen, divided by total patient time on study
Secondary Outcomes
- Time to Room Air(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)(First 7 days of hospitalization)
- ICU Length of Stay(From time of emergency department arrival until the date of ICU discharge or death, assessed up to 180 days)
- Episodes of Hypoxia (SpO2< 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%)(From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days)
- Ventilator Free Day(From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days)
- Hospital Length of Stay(From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days)
- Hospital Discharge Disposition(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)