Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

NCT03789396 | Completed Results

• 1 other identifier: 18-1528
• Study Type: observational
• Target: 572
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma; Critical Illness; Oxygen Toxicity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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

Study Arms (2)

Pre-implementation

The control groups will be trauma patients admitted to the ICU 12 months prior to targeted normoxia

Other: Usual Care Oxygenation

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%)

Interventions

Targeted Normoxia (oxygen saturation 90-96%) OTHER

The intervention (post-implementation) group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation

Post-implementation

Usual Care Oxygenation OTHER

The control (pre-implementation) group will be trauma patients admitted to the ICU during the 12 months prior to the targeted normoxia implementation

Pre-implementation

Eligibility Criteria

• Age: 18 Years - 109 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill trauma patients

You may qualify if:

• Acute Injury/Trauma
• Arrival to Emergency Department

You may not qualify if:

• \<18 years of age
• Known prisoners

Sponsors & Collaborators

• University of Colorado, Denver: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 34039929 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Critical Illness; Hypoxia; Hyperoxia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Results Point of Contact

• Title: Adit Ginde, MD, MPH
• Organization: University of Colorado

ADIT.GINDE@CUANSCHUTZ.EDU

720-848-6777

Study Officials

• Adit Ginde, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 28, 2018
• Study Start: January 1, 2018
• Primary Completion: September 19, 2019
• Study Completion: October 1, 2022
• Last Updated: February 15, 2024
• Results First Posted: February 15, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)