CClinicalTrials.gg
CompletedNCT01746576Updated Apr 16, 2014

Use of Near Infrared Spectroscopy to Measure Intracranial ScvO2

An interventional study of Use of impedance threshold device during spontaneous ventilation in Healthy, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-16.

Sponsored by University of Virginia · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether analysis of near infrared absorbance signals that occur at different frequencies might provide information about the difference in oxygen saturation between arterial and venous blood.

02

Conditions studied

  • Healthy

Keywords

  • volunteers
03

In context

Lead sponsor

University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult 18-65 years of age

Exclusion criteria

Exclusion Criteria:

  • Dilated cardiomyopathy
  • Congestive heart failure
  • Pulmonary hypertension
  • Severe aortic stenosis
  • Flail chest
  • Chest pain
  • Shortness of breath
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    All

    All subjects will undergo spontaneous ventilation through an impedance threshold device and ScvO2 will be recorded before and after

    Other: Use of impedance threshold device during spontaneous ventilation

Interventions

  • OtherUse of impedance threshold device during spontaneous ventilation
06

What researchers measure

Primary outcomes

  1. Estimated venous oxygen saturation

    Oxygen saturation will be calculated from the five minute period of time prior to use of the impedance threshold device (0-4 mins), and then again in the 2 minute period after the impedance threshold device is applied (5-6 mins)

    Time frame: From 5 to 6:59 minutes after applying the impedance threshold device

07

Study locations

1 site
  • University of Virginia
    Charlottesville, Virginia 22908, United States
08

References and documents

Publications

  • Thiele RH, Tucker-Schwartz JM, Lu Y, Gillies GT, Durieux ME. Transcutaneous regional venous oximetry: a feasibility study. Anesth Analg. 2011 Jun;112(6):1353-7. doi: 10.1213/ANE.0b013e3182166a26. PubMed 21613200 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01746576
Lead sponsor
University of Virginia
Responsible party
Robert Thiele, MD (Assistant Professor, University of Virginia) — Principal investigator
First posted
Dec 11, 2012
Start date
Sep 2012
Primary completion
Sep 2013
Completion
Sep 2013
Last update
Apr 16, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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