NCT00881829

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
7.3 years until next milestone

Study Start

First participant enrolled

August 9, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2021

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

5.4 years

First QC Date

April 13, 2009

Last Update Submit

February 24, 2021

Conditions

Hypoxia

Keywords

Pulse OximetryTemperatureRespiratory RateRespiratory GasesThis study determine the measurement accuracy of the physiological parameters

Outcome Measures

Primary Outcomes (1)

  • Completion of study by all subjects

    5 years

Study Arms (1)

Healthy volunteer

Smoker or non-smoker

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

Interventions

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

Measurement of physiological parameters.

Healthy volunteer

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Residents of the Denver metropolitan area.

You may qualify if:

  • healthy individuals between the age of 18-50 years.

You may not qualify if:

  • Clotting disorders, diabetes, currently taking psychotropic medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinimark Laboratories

Louisville, Colorado, 80027, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia

Interventions

Blood PressureRespiratory RateBody Temperature

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaRespirationRespiratory Physiological PhenomenaPhysiological Phenomena

Study Officials

  • David Ransom, MD

    Avista Adventist Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dena M Raley, BSBE

CONTACT

303-249-6010DMRaley@Clinimark.com

Paul B Batchelder, RRT

CONTACT

303-717-4820PBatchelder@Clinimark.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator, Clinimark

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 15, 2009

Study Start

August 9, 2016

Primary Completion

December 21, 2021

Study Completion

December 21, 2021

Last Updated

February 26, 2021

Record last verified: 2021-02

Locations

US(1)