Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in the Emergency Department

• Sponsor: Masimo Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03017742
• Collaborator: (none)
• Enrollment: 813
• Location: 1
• Arm: 1
• Duration (Months): 13.3
• Patients Per Site Per Month: 61.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carbon Monoxide Poisoning; Anemia	Device: Pulse Oximeter

Study Design

• Study Type: Interventional
• Actual Enrollment: 813 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Multi-Center Study on the Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in Emergency Department Patients
• Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Dec 11, 2017
• Actual Study Completion Date: Dec 11, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Group The subjects enrolled in the test group will receive the pulse oximeter	Device: Pulse Oximeter

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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

4. 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.

5. Specificity of SpHb in Detecting Anemia. [up to 3 hours]

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

6. Sensitivity of SpHb Detection of Anemia. [up to 3 hours]

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

7. SpHb Utility for Screening Anemia [up to 3 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tepecik Training and Research Hospital IEC	Izmir		Turkey	468

Sponsors and Collaborators

• Masimo Corporation

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 19, 2016

More Information

Publications

None provided.

• Responsible Party: Masimo Corporation
• ClinicalTrials.gov Identifier: NCT03017742
• Other Study ID Numbers: SUNE0002
• First Posted: Jan 11, 2017
• Last Update Posted: Jul 8, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Emergencies; Poisoning; Carbon Monoxide Poisoning

Study Results

Participant Flow

Arm/Group Title	Test Group
Arm/Group Description	The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
Period Title: Overall Study
STARTED	813
COMPLETED	740
NOT COMPLETED	73

Baseline Characteristics

Arm/Group Title	Test Group
Arm/Group Description	The subjects enrolled in the test group will receive the pulse oximeter Pulse Oximeter
Overall Participants	740
Age (Count of Participants)
<=18 years	52 7%
Between 18 and 65 years	559 75.5%
>=65 years	129 17.4%
Sex: Female, Male (Count of Participants)
Female	399 53.9%
Male	341 46.1%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	740 100%

Outcome Measures

1. Primary Outcome

Title	Difference Between SpCO and COHb
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Test Group
Arm/Group Description	The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
Measure Participants	600
Mean (Standard Deviation) [percent]	2.01 (2.49)

2. Primary Outcome

Title	SpCO Detection of Carbon Monoxide Poisoning (COP)
Description	Diagnostics performance of SpCO for detecting COP measured by sensitivity and specificity compared to COHb.
Time Frame	up to 3 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Test Group
Arm/Group Description	The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
Measure Participants	600
Sensitivity of COP Detection	73.08
Specificity of COP Detection	82.75

3. Primary Outcome

Title	Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning
Description	Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity
Time Frame	up to 3 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Test Group
Arm/Group Description	The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
Measure Participants	0

4. Primary Outcome

Title	Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration
Description	CO elimination will be evaluated as a function of administered oxygen.
Time Frame	up to 3 hours

Outcome Measure Data

Analysis Population Description

No COHb elimination pharmacokinetics data was collected.

Arm/Group Title	Test Group
Arm/Group Description	The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
Measure Participants	0

5. Primary Outcome

Title	Specificity of SpHb in Detecting Anemia.
Description	Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.
Time Frame	up to 3 hours

Outcome Measure Data

Analysis Population Description

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/Group Title	Test Group
Arm/Group Description	The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
Measure Participants	546
Number [percentage of true negative]	81.00

6. Primary Outcome

Title	Sensitivity of SpHb Detection of Anemia.
Description	Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.
Time Frame	up to 3 hours

Outcome Measure Data

Analysis Population Description

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/Group Title	Test Group
Arm/Group Description	The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
Measure Participants	546
Number [percent of true positives]	60.77

7. Primary Outcome

Title	SpHb Utility for Screening Anemia
Description	Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia
Time Frame	up to 3 hours

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Group
Arm/Group Description	The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
Measure Participants	0

Adverse Events

Time Frame	Adverse events were monitored throughout study duration, which was up to three hours.
Arm/Group Title	Test Group
Arm/Group Description	The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters
All Cause Mortality
	Test Group
	Affected / at Risk (%)	# Events
Total	0/813 (0%)
Serious Adverse Events
	Test Group
	Affected / at Risk (%)	# Events
Total	0/813 (0%)
Other (Not Including Serious) Adverse Events
	Test Group
	Affected / at Risk (%)	# Events
Total	0/813 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.