Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

Overview

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.

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 19, 2019

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.

Interventions

  • 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
  • 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

Arms, Groups and Cohorts

  • Pre-implementation
    • The control groups will be trauma patients admitted to the ICU 12 months prior to targeted normoxia
  • Post-implementation
    • The intervention group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Episodes of Hypoxia (SpO2< 88%)
    • Time Frame: 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%)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: First 7 days of hospitalization
    • Acute organ injury as measured by SOFA score
  • ICU Length of Stay
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days
    • Percent of deceased participants

Participating in This Clinical Trial

Inclusion Criteria

  • Acute Injury/Trauma – Arrival to Emergency Department Exclusion Criteria:

  • <18 years of age – Known prisoners

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 109 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Collaborator
    • United States Department of Defense
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Adit Ginde, MD, MPH, Principal Investigator, University of Colorado, Denver

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