NCT01326819

Brief Summary

Observational comparison study of three commercially available regional oxygen saturation devices on a wide range of skin colors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
231

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 31, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 13, 2013

Status Verified

November 1, 2012

Enrollment Period

1.8 years

First QC Date

March 3, 2011

Last Update Submit

May 9, 2013

Conditions

Near Infrared Spectroscopy

Keywords

Near infrared spectroscopySkin pigmentationRegional oxygen saturation

Outcome Measures

Primary Outcomes (1)

  • The mean and standard deviation of readings with all four regional oxygen saturation devices.

    Data analysis will be performed when 240 subjects have been enrolled (7 months)

Eligibility Criteria

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

Community sample

You may qualify if:

  • Male or Female
  • of any race or ethnicity
  • greater than eighteen years of age
  • weighs greater than or equal to 40 kilograms
  • is not currently admitted to the hospital
  • is not known to be pregnant
  • understands English
  • is willing and able to provide informed consent and comply with study procedures

You may not qualify if:

  • is less than eighteen years of age
  • weighs less than 40 kilograms
  • if known to be pregnant
  • is a current patient in the hospital
  • does not understand English
  • has known anemia
  • is unwilling and able to provide informed consent and comply with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kumar Belani, MD

    Univeristy of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2011

First Posted

March 31, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 13, 2013

Record last verified: 2012-11

Locations

US(1)