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NCT01552785 Clinical Trial

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

Near Infrared Spectroscopy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01552785
Other study ID # NIF010312
Secondary ID
Status Completed
Phase N/A
First received March 6, 2012
Last updated June 21, 2012
Start date March 2012
Est. completion date May 2012

Study information
Verified date June 2012
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult

- Double skin fold less than 1 cm on the lower arm

Exclusion Criteria:

- Chronic diseases

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Peripheral near infrared spectroscopy
Devices: NONIN 7600 EQUANOX with sensor Model 8004CA, INVOS 5100c with SAFB-SM, and FORE-SIGHT with medium sensor

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Absolute mean value of peripheral regional tissue oxygenation (rStO2) in percent 3 hours No
Secondary Reproducibility of measurement of peripheral regional tissue oxygenation (rStO2) in percent 3 hours No
Secondary Sensitivity to changes in peripheral regional tissue oxygenation (rStO2) in percent 3 hours No
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