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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01552785
First received: March 6, 2012
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Near Infrared Spectroscopy
 Device: Peripheral near infrared spectroscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Absolute mean value of peripheral regional tissue oxygenation (rStO2) in percent [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reproducibility of measurement of peripheral regional tissue oxygenation (rStO2) in percent [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
  • Sensitivity to changes in peripheral regional tissue oxygenation (rStO2) in percent [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552785

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

No publications provided

Responsible Party: Gorm Greisen, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01552785     History of Changes
Other Study ID Numbers: NIF010312
Study First Received: March 6, 2012
Last Updated: June 21, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

ClinicalTrials.gov processed this record on May 22, 2013