Study of Spectro-photometric Based Systems Measuring Pulse Oximetry and Other Analytes and Physiological Parameters
This study is currently recruiting participants.
Verified October 2012 by Clinimark, LLC
Sponsor:
Clinimark, LLC
Information provided by (Responsible Party):
David Ransom, MD, Clinimark, LLC
ClinicalTrials.gov Identifier:
NCT00881829
First received: April 13, 2009
Last updated: October 8, 2012
Last verified: October 2012
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| First Received Date ICMJE | April 13, 2009 | ||||||||
| Last Updated Date | October 8, 2012 | ||||||||
| Start Date ICMJE | March 2005 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00881829 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Spectro-photometric Based Systems Measuring Pulse Oximetry and Other Analytes and Physiological Parameters | ||||||||
| Official Title ICMJE | Study of Spectro-photometric Based Systems Measuring Pulse Oximetry and Other Analytes and Physiological Parameters | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Hospital and Laboratory data Collection used for Device development and Regulatory Accuracy Submissions. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Residents of the Denver metropolitan area. |
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| Condition ICMJE | Physiological Parameters | ||||||||
| Intervention ICMJE | Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature
Measurement of physiological parameters. |
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| Study Group/Cohort (s) | Healthy volunteer
Smoker or non-smoker
Intervention: Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1000 | ||||||||
| Estimated Completion Date | May 2014 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 80 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00881829 | ||||||||
| Other Study ID Numbers ICMJE | P1000-000-001REV7 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | David Ransom, MD, Clinimark, LLC | ||||||||
| Study Sponsor ICMJE | Clinimark, LLC | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Clinimark, LLC | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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