Dysfunctional Hemoglobin CO-ox | NCT02427685

Studies
Dysfunctional Hemoglobin CO-ox

NCT02427685

Sponsor

Nonin Medical, Inc

Status

Completed

Last Update Posted

Jun 17, 2015Estimated

Enrollment

27Actual

Phase

Not provided

Conditions

Elevated Levels of Carboxyhemoglobin

Interventions

Pulse Co-Ox

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Apr 20, 2015

First Submission Date that Met QC Criteria

Apr 27, 2015

First Posted Date

Apr 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2015

Last Update Posted Date

Jun 17, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Name	Type	Description	Arm Group Labels	Other Names
Pulse Co-Ox	Device	Comparison of pulse co-oximeter to blood gas analyzer.

Measure	Description	Time Frame
Carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry.		3 hours

Measure	Description	Time Frame
Oxygen saturation accuracy in conditions of elevated carboxyhemoglobin.		3 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject is male or female.
The subject is of any racial or ethnic group.
The subject is between 18 years and 45 years of age.
The subject does not have significant medical problems.
The subject is willing to provide written informed consent and is willing and able to comply with study procedures.

Exclusion Criteria:

Has a BMI greater than 31
Has had any relevant injury at the sensor location site
Has deformities or abnormalities that may prevent proper application of the device under test.
Has a known respiratory condition.
Is currently a smoker.
Has a known heart or cardiovascular condition.
Is currently pregnant.
Is female and actively trying to get pregnant.
Has a clotting disorder.
Has Raynaud's Disease.
Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia).
The subject has a COHb greater than 3% or MetHb greater than 2%.
Has taken blood thinners or medication with aspirin within the last 24 hours.
Has unacceptable collateral circulation from the ulnar artery.
Has donated more than 300 mL of blood within one month prior to start of study.
Is unwilling or unable to provide written informed consent to participate in the study.
Is unwilling or unable to comply with the study procedures for the primary objectives.
Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Healthy adult volunteers

Sampling Method

Non-Probability Sample