Anemia, Carbon Monoxide Poisoning
Conditions
Brief summary
The purpose of this study is to determine the clinical utility of triage screening for anemia and carbon monoxide poisoning (COP) in the ED setting.This is a prospective, nonrandomized, multi-center study of the performance of simultaneous non-invasive testing for two common disorders (COP and anemia). We will determine the limits of agreement and performance characteristics of non-invasive carboxyhemoglobin (SpCO) and hemoglobin (SpHb) values compared to standard blood tests for measurement of carboxyhemoglobin and hemoglobin, in the emergency department setting.
Interventions
DEVICEPulse Oximeter
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 1 year or older. * At least one digit has acceptable width as measured by study-provided digit gauge. * Presenting to emergency department for any complaint. * Potential for IV catheter and/or blood draw for CBC as standard of care.
Exclusion criteria
* Patients unable to consent for any reason * Patients with fingernail polish, discoloration or trauma to fingers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between SpCO and COHb | Up to 3 hours | 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. |
| SpCO Detection of Carbon Monoxide Poisoning (COP) | up to 3 hours | Diagnostics performance of SpCO for detecting COP measured by sensitivity and specificity compared to COHb. |
| Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning | up to 3 hours | Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity |
| Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration | up to 3 hours | CO elimination will be evaluated as a function of administered oxygen. |
| Specificity of SpHb in Detecting Anemia. | up to 3 hours | Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer. |
| Sensitivity of SpHb Detection of Anemia. | up to 3 hours | Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer. |
| SpHb Utility for Screening Anemia | up to 3 hours | Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Group The subjects enrolled in the test group will receive the pulse oximeter
Pulse Oximeter | 740 |
| Total | 740 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 36 |
| Overall Study | Withdrawal by Subject | 37 |
Baseline characteristics
| Characteristic | Test Group | — |
|---|---|---|
| Age, Categorical <=18 years | 52 Participants | — |
| Age, Categorical >=65 years | 129 Participants | — |
| Age, Categorical Between 18 and 65 years | 559 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 740 participants | — |
| Sex: Female, Male Female | 399 Participants | — |
| Sex: Female, Male Male | 341 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 813 |
| other Total, other adverse events | 0 / 813 |
| serious Total, serious adverse events | 0 / 813 |
Outcome results
Primary
Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration
CO elimination will be evaluated as a function of administered oxygen.
Time frame: up to 3 hours
Population: No COHb elimination pharmacokinetics data was collected.
Primary
Difference Between SpCO and COHb
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Difference Between SpCO and COHb | 2.01 percent | Standard Deviation 2.49 |
Primary
Sensitivity of SpHb Detection of Anemia.
Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Group | Sensitivity of SpHb Detection of Anemia. | 60.77 percent of true positives |
Primary
SpCO Detection of Carbon Monoxide Poisoning (COP)
Diagnostics performance of SpCO for detecting COP measured by sensitivity and specificity compared to COHb.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Group | SpCO Detection of Carbon Monoxide Poisoning (COP) | Sensitivity of COP Detection | 73.08 percentage |
| Test Group | SpCO Detection of Carbon Monoxide Poisoning (COP) | Specificity of COP Detection | 82.75 percentage |
Primary
Specificity of SpHb in Detecting Anemia.
Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Group | Specificity of SpHb in Detecting Anemia. | 81.00 percentage of true negative |
Primary
SpHb Utility for Screening Anemia
Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia
Time frame: 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.
Primary
Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning
Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity
Time frame: up to 3 hours
Population: Clinician survey were not conducted or collected to perform data analysis.