Trial Outcomes & Findings for Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients (NCT NCT03789396)
NCT ID: NCT03789396
Last Updated: 2024-02-15
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
572 participants
Primary outcome timeframe
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
Results posted on
2024-02-15
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
371
|
201
|
|
Overall Study
COMPLETED
|
371
|
201
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients
Baseline characteristics by cohort
| Measure |
Pre-implementation
n=371 Participants
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
|
Post-implementation
n=201 Participants
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
|
Total
n=572 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 21.4 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 21.4 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 21.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
258 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
397 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
83 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
243 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
377 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
45 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
194 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
128 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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, 2019Total 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
Outcome measures
| Measure |
Pre-implementation
n=371 Participants
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
|
Post-implementation
n=201 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
|
|---|---|---|
|
Patient-time Hyperoxic and Not on Room Air
|
40.6 Percent patient-time in hyperoxia
Standard Error 2.5
|
33.9 Percent patient-time in hyperoxia
Standard Error 3.3
|
SECONDARY outcome
Timeframe: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 daysSpO2 saturations below 88%. Episodes of hypoxia reported in minutes (i.e. one episode of hypoxia = one minute spent).
Outcome measures
| Measure |
Pre-implementation
n=371 Participants
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
|
Post-implementation
n=201 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
|
|---|---|---|
|
Episodes of Hypoxia (SpO2< 88%)
|
12 Minutes
Interval 0.0 to 75.0
|
14 Minutes
Interval 0.0 to 70.0
|
SECONDARY outcome
Timeframe: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 daysSpO2 saturations above 96%. Episodes of hyperoxia reported in minutes (i.e. one episode of hyperoxia = one minute spent).
Outcome measures
| Measure |
Pre-implementation
n=371 Participants
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
|
Post-implementation
n=201 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
|
|---|---|---|
|
Episodes of Hyperoxia (SpO2 >96%)
|
3151 Minutes
Interval 1274.0 to 5559.0
|
3037 Minutes
Interval 1455.0 to 5010.0
|
SECONDARY outcome
Timeframe: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 daysVentilator Free Days = Days off ventilator
Outcome measures
| Measure |
Pre-implementation
n=371 Participants
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
|
Post-implementation
n=201 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
|
|---|---|---|
|
Ventilator Free Day
|
28 Days
Interval 24.0 to 28.0
|
28 Days
Interval 24.0 to 28.0
|
SECONDARY outcome
Timeframe: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 daysDuration of supplemental oxygen use measured in days
Outcome measures
| Measure |
Pre-implementation
n=371 Participants
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
|
Post-implementation
n=201 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
|
|---|---|---|
|
Time to Room Air
|
2 Days
Interval 0.0 to 4.0
|
2 Days
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: First 7 days of hospitalizationPopulation: 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.).
Acute organ injury as measured by SOFA score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From time of emergency department arrival until the date of ICU discharge or death, assessed up to 180 daysNumber of days spent in the ICU
Outcome measures
| Measure |
Pre-implementation
n=371 Participants
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
|
Post-implementation
n=201 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
|
|---|---|---|
|
ICU Length of Stay
|
10.9 Days
Standard Deviation 26.8
|
10.4 Days
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 daysNumber of days spent in the hospital
Outcome measures
| Measure |
Pre-implementation
n=371 Participants
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
|
Post-implementation
n=201 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
|
|---|---|---|
|
Hospital Length of Stay
|
6 Days
Interval 3.0 to 13.0
|
7 Days
Interval 4.0 to 15.0
|
SECONDARY outcome
Timeframe: Date of hospital discharge, assessed up to 180 daysPercent of patients discharged to home or facility vs death or hospice = measuring illness at discharge
Outcome measures
| Measure |
Pre-implementation
n=371 Participants
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
|
Post-implementation
n=201 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
|
|---|---|---|
|
Hospital Discharge Disposition
|
71.4 Percent of patients as described
Standard Error 2.3
|
71.1 Percent of patients as described
Standard Error 3.2
|
SECONDARY outcome
Timeframe: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 daysPercent of deceased participants
Outcome measures
| Measure |
Pre-implementation
n=371 Participants
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
|
Post-implementation
n=201 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
|
|---|---|---|
|
Hospital Mortality
|
21 Participants
|
16 Participants
|
Adverse Events
Pre-implementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-implementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place