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

NCT ID: NCT03017742

Last Updated: 2022-07-08

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

813 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-12-11

Brief Summary

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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.

Detailed Description

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Conditions

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Carbon Monoxide Poisoning Anemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Test Group

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

Group Type EXPERIMENTAL

Pulse Oximeter

Intervention Type DEVICE

Interventions

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Pulse Oximeter

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masimo Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tepecik Training and Research Hospital IEC

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SUNE0002

Identifier Type: -

Identifier Source: org_study_id

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