NCT03017742

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
813

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2017

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

July 8, 2022

Completed
Last Updated

July 8, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

January 9, 2017

Results QC Date

August 30, 2021

Last Update Submit

June 14, 2022

Conditions

Carbon Monoxide PoisoningAnemia

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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

    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.

    up to 3 hours

  • Specificity of SpHb in Detecting Anemia.

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

    up to 3 hours

  • Sensitivity of SpHb Detection of Anemia.

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

    up to 3 hours

  • SpHb Utility for Screening Anemia

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

    up to 3 hours

Study Arms (1)

Test Group

EXPERIMENTAL

The subjects enrolled in the test group will receive the pulse oximeter

Device: Pulse Oximeter

Interventions

Pulse OximeterDEVICE
Test Group

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tepecik Training and Research Hospital IEC

Izmir, 468, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carbon Monoxide PoisoningAnemia

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced DisordersHematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Cristina Johnson
Organization
Masimo Corporation
clinicalresearchdept@masimo.com
(949) 297-7000

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 11, 2017

Study Start

November 1, 2016

Primary Completion

December 11, 2017

Study Completion

December 11, 2017

Last Updated

July 8, 2022

Results First Posted

July 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)