NCT01552785

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 22, 2012

Status Verified

June 1, 2012

Enrollment Period

2 months

First QC Date

March 6, 2012

Last Update Submit

June 21, 2012

Conditions

Near Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Absolute mean value of peripheral regional tissue oxygenation (rStO2) in percent

    3 hours

Secondary Outcomes (2)

  • Reproducibility of measurement of peripheral regional tissue oxygenation (rStO2) in percent

    3 hours

  • Sensitivity to changes in peripheral regional tissue oxygenation (rStO2) in percent

    3 hours

Study Arms (1)

Healthy adults

Device: Peripheral near infrared spectroscopy

Interventions

Peripheral near infrared spectroscopyDEVICE

Devices: NONIN 7600 EQUANOX with sensor Model 8004CA, INVOS 5100c with SAFB-SM, and FORE-SIGHT with medium sensor

Healthy adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Citizens of Copenhagen

You may qualify if:

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

You may not qualify if:

  • Chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Copenhagen, DK-2100, Denmark

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 13, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 22, 2012

Record last verified: 2012-06

Locations

DK(1)