Trauma
Conditions
Brief summary
This is a prospective, non-blinded, non-randomized, interventional study of the Masimo pulse oximeter and sensors in a trauma setting
Detailed description
The study aimed to evaluate SpHb's ability to detect critical drops in a trauma population
Interventions
DEVICERadical-7 Pulse CO-Oximeter and sensor
Noninvasive device that measures hemoglobin.
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Estimated 16 years of age or older or greater than or equal to 50 kg body weight if age unknown. * Level 1 (highest trauma activation) status at the time of arrival to emergency department (ED). * Expected to be admitted to the ICU/IMU for in hospital care.
Exclusion criteria
* Moribund patients with devastating injuries and expected to die within one hour of ED admission. * Prisoners, as defined as those who have been directly admitted from a correctional facility (a free living individual who is under police observation as a suspect will remain in the study until hospital discharge). * Obvious pregnancy in the ED. * Received greater than 5 minutes of cardiopulmonary resuscitation (CPR) in the pre-arrival or hospital setting. * Has, on the ring, middle and index fingers of both hands, any of the following: finger deformities, injuries, including burns, scar tissue or infection, or any material that may interfere with sensor application or trans-illumination of the site. * Has significant bilateral trauma to the arms or forearms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SpHb's Ability to Detect Critical Drops | Up to 24 hours. | The ability of noninvasive continuous total hemoglobin (SpHb) to detect critical drops in arterial or venous hemoglobin values, calculated using chi-squared analysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Subjects Each test subject will receive a Radical-7 Pulse CO-Oximeter and sensor that will remain on the subject for the first 24 hours following ED admission or discharge from the ICU/IMU.
Radical-7 Pulse CO-Oximeter and sensor: Noninvasive device that measures hemoglobin. | 351 |
| Total | 351 |
Baseline characteristics
| Characteristic | Test Subjects |
|---|---|
| Age, Categorical <=18 years | 24 Participants |
| Age, Categorical >=65 years | 33 Participants |
| Age, Categorical Between 18 and 65 years | 294 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 7 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 95 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/Latino | 92 Participants |
| Race/Ethnicity, Customized Race/Ethnicity More than one race | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Unknown or Not Reported | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 152 Participants |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 281 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 351 |
| other Total, other adverse events | 0 / 351 |
| serious Total, serious adverse events | 0 / 351 |
Outcome results
Primary
SpHb's Ability to Detect Critical Drops
The ability of noninvasive continuous total hemoglobin (SpHb) to detect critical drops in arterial or venous hemoglobin values, calculated using chi-squared analysis.
Time frame: Up to 24 hours.
Population: Sufficient number of cases to meet sample size criteria for assessing outcomes was not achieved. The protocol required a minimum of 50 subjects with at least 2 blood samples to conduct an interim analysis to calculate final sample size in order to obtain to a definition of critical drop detection. This study was not able to meet this target and therefore a critical drop could not be defined (primary outcome measure).