Study of Spectro-photometric Based Systems Measuring Pulse Oximetry and Other Analytes and Physiological Parameters

This study is currently recruiting participants.
Verified September 2013 by Clinimark, LLC
Sponsor:
Information provided by (Responsible Party):
David Ransom, MD, Clinimark, LLC
ClinicalTrials.gov Identifier:
NCT00881829
First received: April 13, 2009
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

Development and accuracy study of physiological monitoring devices including Pulse Oximetry, Carbon Monoxide, Met Hemoglobin, Blood Pressure, Temperature, Glucose, Respiratory Gasses, Respiratory Rate, Temperature-Thermoregulation, Ventilation-Ventilators, Airway Devices (Endotracheal Tubes).

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


Condition Intervention
Physiological Parameters
Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Spectro-photometric Based Systems Measuring Pulse Oximetry and Other Analytes and Physiological Parameters

Further study details as provided by Clinimark, LLC:

Primary Outcome Measures:
  • Completion of study by all subjects [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: March 2005
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy volunteer
Smoker or non-smoker
Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature
Measurement of physiological parameters.

Detailed Description:

Hospital and Laboratory data Collection used for Device development and Regulatory Accuracy Submissions.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Residents of the Denver metropolitan area.

Criteria

Inclusion Criteria:

  • healthy individuals between the age of 1hr and 80years.

Exclusion Criteria:

  • Clotting disorders, diabetes, currently taking psychotropic medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881829

Contacts
Contact: Dena M Raley, BSBE 303-249-6010 DMRaley@Clinimark.com
Contact: Paul B Batchelder, RRT 303-717-4820 PBatchelder@Clinimark.com

Locations
United States, Colorado
Clinimark Laboratories Recruiting
Louisville, Colorado, United States, 80027
Contact: Paul B Batchelder, RRT    303-717-4820    PBatchelder@Clinimark.com   
Sub-Investigator: Paul B Batchelder, RRT, LRCP         
Sponsors and Collaborators
Clinimark, LLC
Investigators
Principal Investigator: David Ransom, MD Avista Adventist Hospital
  More Information

No publications provided

Responsible Party: David Ransom, MD, Primary Investigator, Clinimark, Clinimark, LLC
ClinicalTrials.gov Identifier: NCT00881829     History of Changes
Other Study ID Numbers: P1000-000-001REV7
Study First Received: April 13, 2009
Last Updated: September 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Clinimark, LLC:
Pulse Oximetry
Blood Pressure
Temperature
Respiratory Rate
Respiratory Gases
This study determine the measurement accuracy of the physiological parameters

ClinicalTrials.gov processed this record on April 17, 2014