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

June 21, 2012 updated by: Gorm Greisen, Rigshospitalet, Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Citizens of Copenhagen

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Chronic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute mean value of peripheral regional tissue oxygenation (rStO2) in percent
Time Frame: 3 hours
3 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Reproducibility of measurement of peripheral regional tissue oxygenation (rStO2) in percent
Time Frame: 3 hours
3 hours
Sensitivity to changes in peripheral regional tissue oxygenation (rStO2) in percent
Time Frame: 3 hours
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 9, 2012

First Posted (Estimate)

March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • NIF010312

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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