Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

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 Overview

• Status: Completed
• Conditions: Critical Illness; Trauma; Oxygen Toxicity
• Intervention / Treatment: Other: Usual Care Oxygenation; Other: Targeted Normoxia (oxygen saturation 90-96%)

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.

• Study Type: Observational
• Enrollment (Actual): 572

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 109 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Critically ill trauma patients

Description

Inclusion Criteria:

• Acute Injury/Trauma
• Arrival to Emergency Department

Exclusion Criteria:

• <18 years of age
• Known prisoners

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-time Hyperoxic and Not on Room Air	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Episodes of Hypoxia (SpO2< 88%)	SpO2 saturations below 88%. Episodes of hypoxia reported in minutes (i.e. one episode of hypoxia = one minute spent).	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%. Episodes of hyperoxia reported in minutes (i.e. one episode of hyperoxia = one minute spent).	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 use measured in days	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	Percent of patients discharged to home or facility vs death or hospice = measuring illness at discharge	Date of hospital discharge, assessed up to 180 days
Hospital Mortality	Percent of deceased participants	From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Adit Ginde, MD, MPH, University of Colorado, Denver

Publications and helpful links

General Publications

• Kuroda N, Tsutsumi Y, Banno M. Does statistical difference in the pre/post-quasi-experimental study mean the utility of multimodal educational intervention in targeted normoxia in critically ill trauma patients? J Trauma Acute Care Surg. 2021 Aug 1;91(2S Suppl 2):S269-S270. doi: 10.1097/TA.0000000000003301. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): September 19, 2019
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (Actual): December 28, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Hypoxia; Critical Illness; Trauma; Oxygenation; Hyperoxia; Normoxia
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Wounds and Injuries; Critical Illness
• Other Study ID Numbers: 18-1528

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No