SpO2 Accuracy Validation of Pulse Oximetry Systems During... | NCT02475668

Studies
SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions

NCT02475668

Sponsor

Nonin Medical, Inc

Status

Completed

Last Update Posted

Jul 10, 2015Estimated

Enrollment

13Actual

Phase

Not provided

Conditions

Hypoxia

Interventions

Pulse oximeter

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

Jul 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

Jun 2015

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jun 16, 2015

First Submission Date that Met QC Criteria

Jun 16, 2015

First Posted Date

Jun 19, 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

Jul 9, 2015

Last Update Posted Date

Jul 10, 2015Estimated

Name	Class
Clinimark, LLC	OTHER

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

13Actual

Name	Type	Description	Arm Group Labels	Other Names
Pulse oximeter	Device	Hypoxia

Measure	Description	Time Frame
accuracy value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion		3 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject is male or female
The subject is of any racial or ethnic group
The subject is > 30 kg (>66 pounds) in weight (self-reported)
The subject has at least one finger height of 0.2 - 1.0 inch (based on measurement)
The subject is between 18 years and 45 years of age (self=reported)
The subject shows no evidence of medical problems as indicated by satisfactory completion of the health assessment form
The subject has given written informed consent to participate in the study
The subject is both willing and able to comply with study procedures.

Exclusion Criteria:

The subject has a BMI greater than 31 (based on weight and height)
The subject has had any relevant injury at the sensor location site (self-reported)
The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination)
The subject is current smoker (self-reported)
The subject has a known respiratory condition (self-reported)
The subject has a known heart or cardiovascular condition (self-reported)
The subject is currently pregnant (self-reported)
The subject is actively trying to get pregnant (self-reported)
The subject has a clotting disorder (self-reported)
The subject has Raynaud's Disease (self-reported)
The subject is known to have a hemoglobinopathy (self-reported)
The subject is on blood thinners or medication with aspirin (self-reported)
The subject has unacceptable collateral circulation from the ulnar artery (based on examination)
The subject is unwilling or unable to provide written informed consent to participate in the study
The subject is unwilling or unable to comply with the study procedures
The subject 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 volunteers

Sampling Method

Non-Probability Sample

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms