Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

• ClinicalTrials.gov Identifier: NCT03789396
• Recruitment Status: Active, not recruiting
• First Posted: December 28, 2018
• Last Update Posted: June 24, 2021
• Sponsor: University of Colorado, Denver
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

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.

Condition or disease	Intervention/treatment
Trauma; Critical Illness; Oxygen Toxicity	Other: Targeted Normoxia (oxygen saturation 90-96%); Other: Usual Care Oxygenation

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 618 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Target Follow-Up Duration: 28 Days
• Official Title: Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients
• Actual Study Start Date: January 14, 2019
• Actual Primary Completion Date: September 19, 2019
• Estimated Study Completion Date: October 2022

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Oxygen by volume [ Time Frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days ]
   Volume of oxygen administered during hospital stay

Secondary Outcome Measures :

1. 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%
2. 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%
3. 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
4. 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
5. Measured by daily Sequential Organ Failure Assessment (SOFA) [ Time Frame: First 7 days of hospitalization ]
   Acute organ injury as measured by SOFA score
6. 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
7. 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
8. Hospital discharge disposition [ Time Frame: Date of hospital discharge, assessed up to 180 days ]
   Discharged to facility or home = measuring illness at discharge
9. Hospital Mortality [ Time Frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 109 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Critically ill trauma patients

Criteria

Inclusion Criteria:

• Acute Injury/Trauma
• Arrival to Emergency Department

Exclusion Criteria:

• <18 years of age
• Known prisoners

Contacts and Locations

Locations

United States, Colorado

University of Colorado Hospital

Aurora, Colorado, United States, 80045

Sponsors and Collaborators

University of Colorado, Denver

United States Department of Defense

Investigators

• Principal Investigator: Adit Ginde, MD, MPH; University of Colorado, Denver

More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03789396
• Other Study ID Numbers: 18-1528
• First Posted: December 28, 2018
• Last Update Posted: June 24, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:

Oxygenation; Hypoxia; Normoxia; Hyperoxia; Trauma; Critical Illness

Additional relevant MeSH terms:

Critical Illness; Wounds and Injuries; Disease Attributes; Pathologic Processes