- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01746576
Use of Near Infrared Spectroscopy to Measure Intracranial ScvO2
April 15, 2014 updated by: Robert Thiele, MD, University of Virginia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
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
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia
-
-
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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult 18-65 years of age
Exclusion Criteria:
- Dilated cardiomyopathy
- Congestive heart failure
- Pulmonary hypertension
- Severe aortic stenosis
- Flail chest
- Chest pain
- Shortness of breath
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: All
All subjects will undergo spontaneous ventilation through an impedance threshold device and ScvO2 will be recorded before and after
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimated venous oxygen saturation
Time Frame: From 5 to 6:59 minutes after applying the impedance threshold device
|
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)
|
From 5 to 6:59 minutes after applying the impedance threshold device
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
September 1, 2012
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
October 29, 2012
First Submitted That Met QC Criteria
December 7, 2012
First Posted (Estimate)
December 11, 2012
Study Record Updates
Last Update Posted (Estimate)
April 16, 2014
Last Update Submitted That Met QC Criteria
April 15, 2014
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 16422
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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