SpO2 Hypoxia Accuracy Validation Study | NCT03348189

Studies
SpO2 Hypoxia Accuracy Validation Study

NCT03348189

Sponsor

Nonin Medical, Inc

Status

Completed

Last Update Posted

Nov 20, 2017Actual

Enrollment

12Actual

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

Oct 2017

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

Nov 1, 2017Actual

Primary Completion Date

Nov 3, 2017Actual

Completion Date

Nov 3, 2017Actual

First Submitted Date

Nov 15, 2017

First Submission Date that Met QC Criteria

Nov 15, 2017

First Posted Date

Nov 20, 2017Actual

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

Nov 15, 2017

Last Update Posted Date

Nov 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of this study is to evaluate the % oxygen saturation by pulse oximetry accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.

Detailed Description

The primary objective of this study is to evaluate the %SpO2 accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.

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

12Actual

Label	Type	Description	Intervention Names
Observational		Healthy males and females	Other: Pulse Oximeter

Name	Type	Description	Arm Group Labels	Other Names
Pulse Oximeter	Other	Pulse Oximeter	Observational

Measure	Description	Time Frame
SpO2 Hypoxia Accuracy Validation Study	Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.	Through study completion, 3 months average

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 50 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, is actively trying to get pregnant, or who has a positive urine pregnancy test on the day of the study
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

50 Years

Standard Ages

Adult

Study Population

A minimum of 12 subjects will be enrolled. The subject population will include both male and female subjects with a variety of skin tones.

Sampling Method

Non-Probability Sample

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