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Completed

NCT Number: NCT03789396

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.

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Key information

Conditions

Trauma Critical Illness Disease Attributes Hyperoxia Hypoxia Oxygen Toxicity Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Wounds and Injuries

Age range

18 year–109 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

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:

  • improve the proportion of time spent with target normoxia thresholds (oxygen saturation SpO2 90-96%) by
  • reducing utilization of unnecessary supplementation oxygen
  • without a substantive increase in hypoxic episodes or an adverse impact on clinical outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute Injury/Trauma
  • Arrival to Emergency Department

Exclusion criteria

  • <18 years of age
  • Known prisoners

Treatment and study plan

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

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

Primary outcomes

  1. Patient-time Hyperoxic and Not on Room Air

    Time frame: 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

    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

Secondary outcomes

  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%. Episodes of hypoxia reported in minutes (i.e. one episode of hypoxia = one minute spent).

  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%. Episodes of hyperoxia reported in minutes (i.e. one episode of hyperoxia = one minute spent).

  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 use measured in days

  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

    Percent of patients discharged to home or facility vs death or hospice = 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

    Percent of deceased participants

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Dec 28, 2018
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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