Carbon Monoxide PoisoningNCT03017742

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

A study testing Pulse Oximeter in people with Carbon Monoxide Poisoning and Anemia, run by Masimo Corporation at 1 site in Turkey (Türkiye).

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 1 year and older
Conditions the study is for: Carbon Monoxide Poisoning, Anemia
What is being tested?: Pulse Oximeter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 813 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Nov 2016to 11 Dec 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

Patients unable to consent for any reason
Patients with fingernail polish, discoloration or trauma to fingers

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Tepecik Training and Research Hospital IEC
Izmir, 468

Other trials in Turkey (Türkiye)

About this study

Official title: A Multi-Center Study on the Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in Emergency Department Patients

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.

Conditions: Carbon Monoxide Poisoning, Anemia
Being tested: Pulse Oximeter
Medical subject headings: Carbon Monoxide Poisoning, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pulse OximeterDevice

Study groups in NCT03017742
Study group	Role	What they receive
Test Group	Experimental	The subjects enrolled in the test group will receive the pulse oximeter Receives: Device: Pulse Oximeter

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 3 hours
SpCO Detection of Carbon Monoxide Poisoning (COP)
Diagnostics performance of SpCO for detecting COP measured by sensitivity and specificity compared to COHb.
Measured: up to 3 hours
Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning
Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity
Measured: up to 3 hours
Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration
CO elimination will be evaluated as a function of administered oxygen.
Measured: up to 3 hours
Specificity of SpHb in Detecting Anemia.
Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.
Measured: up to 3 hours
Sensitivity of SpHb Detection of Anemia.
Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.
Measured: up to 3 hours
SpHb Utility for Screening Anemia
Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia
Measured: up to 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201611 Dec 2017

First posted11 Jan 2017 (estimated)
Study startNov 2016
Primary completion11 Dec 2017
Study completion11 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carbon Monoxide PoisoningStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 813 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03017742
Sponsor's protocol ID: SUNE0002
Status last verified: Jun 2022
First submitted: 9 Jan 2017
Last updated: 8 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 4
The Efficacy of Dexamethasone in Combination With N-acetylcysteine in Preventing Neurocognitive Sequelae Due to Carbon Monoxide Poisoning
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Microparticles Blood Level in Acute Carbon Monoxide Poisoning
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RecruitingObservational study
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All Carbon Monoxide Poisoning trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center Study on the Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in Emergency Department Patients
ClinicalTrials.gov ID: NCT03017742
Acronym / sponsor ID: SUNE0002
Conditions: Carbon Monoxide Poisoning, Anemia
Study type: Interventional
Recruitment status: Terminated
Enrolment: 813 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: Nov 2016
Primary completion: 11 Dec 2017 (actual)
Study completion: 11 Dec 2017 (actual)
First posted: 11 Jan 2017 (estimated)
Results: Posted 8 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Test Group	Experimental	Device: Pulse OximeterThe subjects enrolled in the test group will receive the pulse oximeter

Who may qualify

Ages: 1 year and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

Patients unable to consent for any reason
Patients with fingernail polish, discoloration or trauma to fingers

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pulse Oximeter	Device	Test Group

Primary outcome

Difference Between SpCO and COHb
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: up to 3 hours
CO elimination will be evaluated as a function of administered oxygen.
Specificity of SpHb in Detecting Anemia.
Time frame: up to 3 hours
Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.
Sensitivity of SpHb Detection of Anemia.
Time frame: up to 3 hours
Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.
SpHb Utility for Screening Anemia
Time frame: up to 3 hours
Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia

Results and safety

Results posted to the registry on 8 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Group	813	740

Primary outcome: Difference Between SpCO and COHb

Time frame: Up to 3 hours. Mean (Standard Deviation). Unit: percent

Measure	Test Group n = 600
Value	2.01 (2.49)

Population analysed: 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.

Primary outcome: SpCO Detection of Carbon Monoxide Poisoning (COP)

Time frame: up to 3 hours. Number. Unit: percentage

Measure	Test Group n = 600
Sensitivity of COP Detection	73.08
Specificity of COP Detection	82.75

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

Primary outcome: Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning

Time frame: up to 3 hours

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

Primary outcome: Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration

Time frame: up to 3 hours

Population analysed: No COHb elimination pharmacokinetics data was collected.

Adverse events

Time frame: Adverse events were monitored throughout study duration, which was up to three hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Group	0 of 813 (0%)	0 of 813 (0%)	0 of 813

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Carbon Monoxide Poisoning

Not yet recruitingPhase 1/2
Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy
Carbon Monoxide Poisoning, Carbon Monoxide Intoxication
Not yet recruitingObservational study
Prenatal Tobacco Exposure and Newborn Outcomes: A Maternal Urinary Cotinine Study
Tobacco Smoke Pollution, Maternal Exposure During Pregnancy
RecruitingPhase 4
The Efficacy of Dexamethasone in Combination With N-acetylcysteine in Preventing Neurocognitive Sequelae Due to Carbon Monoxide Poisoning
Carbon Monoxide Poisoning, Delayed Neurocognitive Sequelae
RecruitingObservational study
Microparticles Blood Level in Acute Carbon Monoxide Poisoning
Carbon Monoxide Poisoning
RecruitingObservational study
CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)
Carbon Monoxide Poisoning, Myocardial Injury

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pulse Oximeter in people with Carbon Monoxide Poisoning and Anemia, run by Masimo Corporation at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference Between SpCO and COHb (time frame: Up to 3 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03017742.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.