Recruiting

Observational Study

Sponsor:

Clinimark, LLC

Code:

NCT00881829

Conditions

Hypoxia

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

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

Study Details

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.

Conditions

Hypoxia

Study ID

NCT00881829

Start date

Aug 9, 2016

Status verified date

Feb, 2021

Completion date

Dec 21, 2021

Anticipated

Primary completion date

Dec 21, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Clotting disorders, diabetes, currently taking psychotropic medications.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy volunteer

Smoker or non-smoker

Interventions

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

Measurement of physiological parameters.

Primary outcome measure

  • Completion of study by all subjects [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Dena M Raley, BSBE

303-249-6010DMRaley@Clinimark.com

Paul B Batchelder, RRT

303-717-4820PBatchelder@Clinimark.com

Locations

Clinimark Laboratories

Recruiting

Louisville, Colorado, United States, 80027

Contacts

Paul B Batchelder, RRT

303-717-4820PBatchelder@Clinimark.com

More Information

Sponsor

Clinimark, LLC

Last update posted

Feb 26, 2021

Last verified

Feb, 2021

Keywords

  • Pulse Oximetry
  • Temperature
  • Respiratory Rate
  • Respiratory Gases
  • This study determine the measurement accuracy of the physiological parameters

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Clinimark, LLC on 2021-02-26.