Trial Outcomes & Findings for Evaluation of Non-Invasive Hemoglobin in Trauma Patients (NCT NCT03123328)

Last Updated: 2021-04-27

Results Overview

The ability of noninvasive continuous total hemoglobin (SpHb) to detect critical drops in arterial or venous hemoglobin values, calculated using chi-squared analysis.

Recruitment status

COMPLETED

Study phase

Target enrollment

380 participants

Primary outcome timeframe

Up to 24 hours.

Results posted on

2021-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	380
Overall Study COMPLETED	351
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Non-Invasive Hemoglobin in Trauma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Subjects n=351 Participants 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.
Age, Categorical <=18 years	24 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	294 Participants n=5 Participants
Age, Categorical >=65 years	33 Participants n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants
Sex: Female, Male Male	281 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	7 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black or African American	95 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	152 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · More than one race	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Unknown or Not Reported	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic/Latino	92 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

The ability of noninvasive continuous total hemoglobin (SpHb) to detect critical drops in arterial or venous hemoglobin values, calculated using chi-squared analysis.

Outcome measures

Outcome data not reported

Adverse Events

Test Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director, Clinical Research

Masimo Corporation

Phone: 949-297-7416

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place