Trial Outcomes & Findings for Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in the Emergency Department (NCT NCT03017742)

Results Overview

Measure the difference between noninvasive carboxyhemoglobin (SpCO) and carboxyhemoglobin determined by co-oximeter measurement of blood (COHb) as calculated in terms of standard deviation. The average difference between paired Masimo noninvasive carboxyhemoglobin (SpCO) and reference carboxyhemoglobin (COHb) determined by co-oximeter measurement of blood represented as mean bias.

Recruitment status

TERMINATED

Target enrollment

813 participants

Primary outcome timeframe

Up to 3 hours

Results posted on

2022-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Test Group The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
Overall Study STARTED	813
Overall Study COMPLETED	740
Overall Study NOT COMPLETED	73

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Group The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
Overall Study Protocol Violation	36
Overall Study Withdrawal by Subject	37

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Group n=740 Participants The subjects enrolled in the test group will receive the pulse oximeter Pulse Oximeter
Age, Categorical <=18 years	52 Participants n=740 Participants
Age, Categorical Between 18 and 65 years	559 Participants n=740 Participants
Age, Categorical >=65 years	129 Participants n=740 Participants
Sex: Female, Male Female	399 Participants n=740 Participants
Sex: Female, Male Male	341 Participants n=740 Participants
Region of Enrollment United States	740 participants n=740 Participants

PRIMARY outcome

Timeframe: Up to 3 hours

Population: 140 subjects excluded due to: 35 subjects: no valid reference COHb measurements available 17 subjects: no SpCO measurements available 65 subjects: COHb sample more than 10 minutes from the SpCO measurement. 22 subjects: low SpCO confidence value 1 subject: invalid reference measurement (COHb) Target subject sample size of 3000 was not met to evaluate difference between SpCO and COHb. The results are reported in terms of standard deviation.

Measure the difference between noninvasive carboxyhemoglobin (SpCO) and carboxyhemoglobin determined by co-oximeter measurement of blood (COHb) as calculated in terms of standard deviation. The average difference between paired Masimo noninvasive carboxyhemoglobin (SpCO) and reference carboxyhemoglobin (COHb) determined by co-oximeter measurement of blood represented as mean bias.

Outcome measures

Outcome measures
Measure	Test Group n=600 Participants The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
Difference Between SpCO and COHb	2.01 percent Standard Deviation 2.49

PRIMARY outcome

Timeframe: up to 3 hours

Population: Out of the 600 subjects that were analyzed from all that were enrolled, only 26 subjects met the criteria for carbon monoxide poisoning.

Diagnostics performance of SpCO for detecting COP measured by sensitivity and specificity compared to COHb.

Outcome measures

Outcome measures
Measure	Test Group n=600 Participants The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
SpCO Detection of Carbon Monoxide Poisoning (COP) Sensitivity of COP Detection	73.08 percentage
SpCO Detection of Carbon Monoxide Poisoning (COP) Specificity of COP Detection	82.75 percentage

PRIMARY outcome

Timeframe: up to 3 hours

Population: Clinician survey were not conducted or collected to perform data analysis.

Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: up to 3 hours

Population: No COHb elimination pharmacokinetics data was collected.

CO elimination will be evaluated as a function of administered oxygen.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: up to 3 hours

Population: Excluded subjects are shown below: 20 subjects: no valid blood reference results 73 subjects: time between the first valid SpHb reading and the venous blood draw exceeded 10 minutes. 32 subjects: low Perfusion Index quality. 3 subjects: low signal stability 26 subjects: low SpHb confidence 18 subjects : no SpHb result displayed. 21 subjects: user error 1 subject: pregnant

Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.

Outcome measures

Outcome measures
Measure	Test Group n=546 Participants The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
Specificity of SpHb in Detecting Anemia.	81.00 percentage of true negative

PRIMARY outcome

Timeframe: up to 3 hours

Population: Excluded subjects are shown below: 20 subjects: no valid blood reference results 73 subjects: time between the first valid SpHb reading and the venous blood draw exceeded 10 minutes. 32 subjects: low Perfusion Index quality. 3 subjects: low signal stability 26 subjects: low SpHb confidence 18 subjects : no SpHb result displayed. 21 subjects: user error 1 subject: pregnant

Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.

Outcome measures

Outcome measures
Measure	Test Group n=546 Participants The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
Sensitivity of SpHb Detection of Anemia.	60.77 percent of true positives

PRIMARY outcome

Timeframe: up to 3 hours

Population: The number of subjects requirement defined by the study protocol were not met in this study, thus the threshold that predicts the outcome of "acute treatment of anemia" cannot be determined nor validated.

Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia

Outcome measures

Outcome data not reported

Adverse Events

Test Group

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

Cristina Johnson

Masimo Corporation

Phone: (949) 297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60