Hypoxia Blood Validation in Multiple Pulse Oximeters | NCT00881829

Studies
Hypoxia Blood Validation in Multiple Pulse Oximeters

NCT00881829

Sponsor

Clinimark, LLC

Status

Unknown status

Last Update Posted

Feb 26, 2021Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Hypoxia

Interventions

Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature

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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 9, 2016Actual

Primary Completion Date

Dec 21, 2021Estimated

Completion Date

Dec 21, 2021Estimated

First Submitted Date

Apr 13, 2009

First Submission Date that Met QC Criteria

Apr 14, 2009

First Posted Date

Apr 15, 2009Estimated

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

Feb 24, 2021

Last Update Posted Date

Feb 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Description Module

Brief Summary

The purpose of this study is to evaluate the SpO2 accuracy and performance of multiple pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation.

This study is observational in nature which quantifies device performance and accuracy in comparison to a Reference Standard.

Detailed Description

The purpose of this study is to evaluate the SpO2 accuracy and performance of pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the pulse oximeters. It is expected that the Accuracy Root Mean Square (Arms) performance of pulse oximeters will meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy volunteer		Smoker or non-smoker	Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature	Device	Measurement of physiological parameters.	Healthy volunteer

Measure	Description	Time Frame
Completion of study by all subjects		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy individuals between the age of 18-50 years.

Exclusion Criteria:

Clotting disorders, diabetes, currently taking psychotropic medications.

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

Residents of the Denver metropolitan area.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dena M Raley, BSBE	Contact	303-249-6010		DMRaley@Clinimark.com
Paul B Batchelder, RRT	Contact	303-717-4820		PBatchelder@Clinimark.com

Overall Officials

Name	Affiliation	Role
David Ransom, MD	Avista Adventist Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinimark Laboratories	Recruiting	Louisville	Colorado	80027	United States

Condition Browse Module

MeSH Terms

ID	Term
D000860	Hypoxia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001794	Blood Pressure
D056152	Respiratory Rate
D001831	Body Temperature

Ancestor Terms

ID	Term
D055986	Vital Signs
D010808	Physical Examination
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided