Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

NCT ID: NCT03789396

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 572 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2022-10-01

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.

Conditions

Trauma; Critical Illness; Oxygen Toxicity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Pre-implementation

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

Usual Care Oxygenation

Intervention Type: OTHER

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.

Targeted Normoxia (oxygen saturation 90-96%)

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Acute Injury/Trauma
• Arrival to Emergency Department

Exclusion Criteria

• <18 years of age
• Known prisoners

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 109 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adit Ginde, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34039929 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-1528

Identifier Type: -

Identifier Source: org_study_id