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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014