NCT00298090

Brief Summary

Measuring tissue oxygen saturation (St02) in the thenar eminence is emerging as a measurement of resuscitation. However, no study to our knowledge has evaluated the effects of an arterial line in the radial artery supplying this muscle bed on St02. This study will attempt to address the interaction between an arterial line and St02 monitoring in the thenar eminence. As most patients who require aggressive resuscitation will have an arterial line, it is important to understand what if any impact this will have on St02 in the same extremity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2006

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

August 2, 2013

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

2.2 years

First QC Date

February 27, 2006

Results QC Date

May 4, 2012

Last Update Submit

November 14, 2014

Conditions

Keywords

Oxygenation

Outcome Measures

Primary Outcomes (1)

  • Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line

    Using near-infrared spectroscopy, the external device recorded raw StO2 values every 3.5 seconds for approximately 5 minutes prior to and immediately following the insertion of a radial arterial catheter on the ipsilateral side. The raw values were then compiled into one-minute averages.

    up to 15 minutes

Study Arms (1)

StO2 values

StO2 monitoring

Device: StO2 monitoring

Interventions

placement of the StO2 device/ external noninvasive

Also known as: external near infrared spectroscopy
StO2 values

Eligibility Criteria

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

ICU patients wiht arterial lines

You may qualify if:

  • Standard of care placement of arterial line
  • years of age or older

You may not qualify if:

  • Pregnant females
  • Nursing mothers
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

San Antonio, Texas, 78229, United States

Location

Related Links

Limitations and Caveats

Eighteen subjects were not included in final analysis due to incomplete data sets; unsuccessful arterial line placement, technical problems in applying StO2 device, unreliable data or partial data.

Results Point of Contact

Title
Jane Youngers
Organization
UTHSCSA

Study Officials

  • Lopez P Peter, M.D.

    University of Texas Health Science Center San Antonio

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

February 27, 2006

First Posted

March 1, 2006

Study Start

January 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

November 26, 2014

Results First Posted

August 2, 2013

Record last verified: 2014-11

Locations