Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

Critical Illness Clinical Trial

Official title:

Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789396
• Other study ID #: 18-1528
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: October 1, 2022

Study information

• Verified date: June 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 572
• Est. completion date: October 1, 2022
• Est. primary completion date: September 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 109 Years

Eligibility

Inclusion Criteria:

• Acute Injury/Trauma
• Arrival to Emergency Department

Exclusion Criteria:

• <18 years of age
• Known prisoners

Related Conditions & MeSH terms

• Critical Illness
• Oxygen Toxicity
• Trauma
• Wounds and Injuries

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Measured by Daily Sequential Organ Failure Assessment (SOFA)	Acute organ injury as measured by SOFA score	First 7 days of hospitalization
Secondary	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
Secondary	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
Secondary	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
Secondary	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