Critical Illness, Oxygen Toxicity, Trauma
Conditions
Keywords
Oxygenation, Hypoxia, Normoxia, Hyperoxia, Trauma, Critical Illness
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.
Interventions
OTHERTargeted 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
OTHERUsual 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
Sponsors
United States Department of Defense
University of Colorado, Denver
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 109 Years
Healthy volunteers
No
Inclusion criteria
* Acute Injury/Trauma * Arrival to Emergency Department
Exclusion criteria
* \<18 years of age * Known prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-time Hyperoxic and Not on Room Air | 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
| Measure | Time frame | Description |
|---|---|---|
| Episodes of Hyperoxia (SpO2 >96%) | 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). |
| Ventilator Free Day | 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 |
| Time to Room Air | 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 |
| Measured by Daily Sequential Organ Failure Assessment (SOFA) | First 7 days of hospitalization | Acute organ injury as measured by SOFA score |
| Episodes of Hypoxia (SpO2< 88%) | 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). |
| Hospital Length of Stay | 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 |
| Hospital Discharge Disposition | 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 |
| Hospital Mortality | From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days | Percent of deceased participants |
| ICU Length of Stay | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 371 |
| 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 | 201 |
| Total | 572 |
Baseline characteristics
| Characteristic | Post-implementation | Total | Pre-implementation |
|---|---|---|---|
| Age, Continuous | 52.5 years STANDARD_DEVIATION 21.4 | 54.3 years STANDARD_DEVIATION 21.4 | 55.3 years STANDARD_DEVIATION 21.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 51 Participants | 134 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 134 Participants | 377 Participants | 243 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants | 61 Participants | 45 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 69 Participants | 49 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 67 Participants | 195 Participants | 128 Participants |
| Race (NIH/OMB) White | 114 Participants | 308 Participants | 194 Participants |
| Sex: Female, Male Female | 62 Participants | 175 Participants | 113 Participants |
| Sex: Female, Male Male | 139 Participants | 397 Participants | 258 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 371 | 0 / 201 |
| other Total, other adverse events | 0 / 371 | 0 / 201 |
| serious Total, serious adverse events | 0 / 371 | 0 / 201 |
Outcome results
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
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-implementation | Patient-time Hyperoxic and Not on Room Air | 40.6 Percent patient-time in hyperoxia | Standard Error 2.5 |
| Post-implementation | Patient-time Hyperoxic and Not on Room Air | 33.9 Percent patient-time in hyperoxia | Standard Error 3.3 |
Comparison: Comparison of patient odds of being hyperoxic and not on room air pre- versus post-interventionp-value: 0.0395% CI: [0.57, 0.97]Regression, Logistic
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).
Time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-implementation | Episodes of Hyperoxia (SpO2 >96%) | 3151 Minutes |
| Post-implementation | Episodes of Hyperoxia (SpO2 >96%) | 3037 Minutes |
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).
Time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-implementation | Episodes of Hypoxia (SpO2< 88%) | 12 Minutes |
| Post-implementation | Episodes of Hypoxia (SpO2< 88%) | 14 Minutes |
Secondary
Hospital Discharge Disposition
Percent of patients discharged to home or facility vs death or hospice = measuring illness at discharge
Time frame: Date of hospital discharge, assessed up to 180 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-implementation | Hospital Discharge Disposition | 71.4 Percent of patients as described | Standard Error 2.3 |
| Post-implementation | Hospital Discharge Disposition | 71.1 Percent of patients as described | Standard Error 3.2 |
Secondary
Hospital Length of Stay
Number of days spent in the hospital
Time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-implementation | Hospital Length of Stay | 6 Days |
| Post-implementation | Hospital Length of Stay | 7 Days |
Secondary
Hospital Mortality
Percent of deceased participants
Time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-implementation | Hospital Mortality | 21 Participants |
| Post-implementation | Hospital Mortality | 16 Participants |
Secondary
ICU Length of Stay
Number of days spent in the ICU
Time frame: From time of emergency department arrival until the date of ICU discharge or death, assessed up to 180 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-implementation | ICU Length of Stay | 10.9 Days | Standard Deviation 26.8 |
| Post-implementation | ICU Length of Stay | 10.4 Days | Standard Deviation 14 |
Secondary
Measured by Daily Sequential Organ Failure Assessment (SOFA)
Acute organ injury as measured by SOFA score
Time frame: First 7 days of hospitalization
Population: 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.).
Secondary
Time to Room Air
Duration of supplemental oxygen use measured in days
Time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-implementation | Time to Room Air | 2 Days |
| Post-implementation | Time to Room Air | 2 Days |
Secondary
Ventilator Free Day
Ventilator Free Days = Days off ventilator
Time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-implementation | Ventilator Free Day | 28 Days |
| Post-implementation | Ventilator Free Day | 28 Days |