Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

Completed

Conditions: Critical Illness
Oxygen Toxicity
Trauma

Interventions: Other: Usual Care Oxygenation
Other: Targeted Normoxia (oxygen saturation 90-96%)

Registration Number: NCT03789396

Lead Sponsor: University of Colorado, Denver

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 572

Inclusion Criteria

Acute Injury/Trauma
Arrival to Emergency Department

Exclusion Criteria

<18 years of age
Known prisoners

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-implementation	Usual Care Oxygenation	The control groups will be trauma patients admitted to the ICU 12 months prior to targeted normoxia
Post-implementation	Targeted Normoxia (oxygen saturation 90-96%)	The intervention group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation.

Primary Outcome Measures

Name	Time	Method
Patient-time Hyperoxic and Not on Room Air	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 Outcome Measures

Name	Time	Method
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 use measured in days
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
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 hypoxia reported in minutes (i.e. one episode of hypoxia = one minute spent).
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%. Episodes of hyperoxia reported in minutes (i.e. one episode of hyperoxia = one minute spent).
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
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	Percent of patients discharged to home or facility vs death or hospice = 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	Percent of deceased participants