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Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789396
Recruitment Status : Active, not recruiting
First Posted : December 28, 2018
Last Update Posted : October 16, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Colorado, Denver

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.

We convened an expert panel 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, our institution will implement this consensus 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.

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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 18, 2019
Estimated Study Completion Date : September 18, 2020

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789396


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

Additional Information:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03789396    
Other Study ID Numbers: 18-1528
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Critical Illness
Wounds and Injuries
Disease Attributes
Pathologic Processes