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A Comparison of Measurements of Peripheral Tissue Oxygenation by NONIN EQUANOX 7600, INVOS 5100c, and FORE-SIGHT

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ClinicalTrials.gov Identifier: NCT01552785
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : June 22, 2012
Sponsor:
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark

Brief Summary:
A comparison of three different devices using near infrared spectroscopy to measure the regional oxygenation. Both absolute values, reproducibility of measurements and sensitivity to changes will be estimated. The study hypothesis is that NONIN EQUANOX 7600 with sensor Model 8004CA, INVOS 5100c with sensor SAFB-SM and FORE-SIGHT with medium sensor have similar characteristics.

Condition or disease Intervention/treatment
Near Infrared Spectroscopy Device: Peripheral near infrared spectroscopy

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : March 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Group/Cohort Intervention/treatment
Healthy adults Device: Peripheral near infrared spectroscopy
Devices: NONIN 7600 EQUANOX with sensor Model 8004CA, INVOS 5100c with SAFB-SM, and FORE-SIGHT with medium sensor



Primary Outcome Measures :
  1. Absolute mean value of peripheral regional tissue oxygenation (rStO2) in percent [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. Reproducibility of measurement of peripheral regional tissue oxygenation (rStO2) in percent [ Time Frame: 3 hours ]
  2. Sensitivity to changes in peripheral regional tissue oxygenation (rStO2) in percent [ Time Frame: 3 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Citizens of Copenhagen
Criteria

Inclusion Criteria:

  • Adult
  • Double skin fold less than 1 cm on the lower arm

Exclusion Criteria:

  • Chronic diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552785


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Rigshospitalet, Denmark

Responsible Party: Gorm Greisen, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01552785     History of Changes
Other Study ID Numbers: NIF010312
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012