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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-implementation | The control groups will be trauma patients admitted to the ICU 12 months prior to targeted normoxia |
| |
| Post-implementation | The intervention group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Episodes of Hyperoxia (SpO2 >96%) |
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill trauma patients
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| Name | Affiliation | Role |
|---|---|---|
| Adit Ginde, MD, MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34039929 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-implementation | The control groups will be trauma patients admitted to the ICU 12 months prior to targeted normoxia 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 |
| FG001 | 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%): The intervention (post-implementation) group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-implementation | The control groups will be trauma patients admitted to the ICU 12 months prior to targeted normoxia (admitted January 1, 201 to December 31, 2018). 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Error | Percent patient-time in hyperoxia | 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 |
|
180 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-implementation | The control groups will be trauma patients admitted to the ICU 12 months prior to targeted normoxia 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adit Ginde, MD, MPH | University of Colorado | 720-848-6777 | ADIT.GINDE@CUANSCHUTZ.EDU |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2019 | Oct 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D016638 | Critical Illness |
| D000860 | Hypoxia |
| D018496 | Hyperoxia |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
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| 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 |
|
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 |
| 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 |
| 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 |
| Measured by Daily Sequential Organ Failure Assessment (SOFA) | Acute organ injury as measured by SOFA score | First 7 days of hospitalization |
| 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 |
| 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 |
| 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 |
| 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 |
| BG001 |
| Post-implementation |
The intervention group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation (admitted January 1, 2019+ to July 1, 2019). 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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%): The intervention (post-implementation) group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation |
|
|
|
| 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). | Posted | Median | Inter-Quartile Range | Minutes | 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). | Posted | Median | Inter-Quartile Range | Minutes | 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 | Posted | Median | Inter-Quartile Range | Days | 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 | Posted | Median | Inter-Quartile Range | 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 | Variables necessary to determine SOFA could not be collected and, therefore, no analysis can be reported (cite: Dylla L, Anderson EL, Douin DJ, et al. A quasiexperimental study of targeted normoxia in critically ill trauma patients. J Trauma Acute Care Surg. 2021;91(2S Suppl 2):S169-S175.). | Posted | First 7 days of hospitalization |
|
|
| Secondary | ICU Length of Stay | Number of days spent in the ICU | Posted | Mean | Standard Deviation | Days | 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 | Posted | Median | Inter-Quartile Range | Days | 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 | Posted | Mean | Standard Error | Percent of patients as described | Date of hospital discharge, assessed up to 180 days |
|
|
|
| Secondary | Hospital Mortality | Percent of deceased participants | Posted | Count of Participants | Participants | From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days |
|
|
|
| 0 |
| 371 |
| 0 |
| 371 |
| 0 |
| 371 |
| EG001 | 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%): The intervention (post-implementation) group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation | 0 | 201 | 0 | 201 | 0 | 201 |
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| D012816 | Signs and Symptoms |