Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Nonin Medical, Inc

Information provided by (Responsible Party):

J&M Shuler

ClinicalTrials.gov Identifier:

NCT01284023

First received: January 25, 2011

Last updated: March 15, 2017

Last verified: March 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

January 25, 2011

Last Updated Date

March 15, 2017

Start Date ^ICMJE

January 2011

Primary Completion Date

August 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Near infrared spectroscopy [ Time Frame: 1 hour ]

Uninjured subjects will lay supine and be monitored for two one hour periods, on separate days.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01284023 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Skin pigmentation [ Time Frame: prior to monitoring ]
due to absorption of hemoglobin and melanin at near infrared wavelengths, skin pigmentation may affect near infrared spectroscopy values. Skin pigmentation values will be recorded on each study participant using the DSM-II (CyberDerm, Broomall, PA) and the IMS SmartProbe (IMS, Portland, ME).
fat depth [ Time Frame: prior to monitoring ]
because the near infrared spectroscopy device measures tissue oxygenation 2-3 cm below the skin, the device may obtain an altered reading or be unable to obtain a reading on subjects with excessive subcutaneous fat. Data on fat depth will be collected on control subjects using the BX2000 (IntelaMetrix, Livermore, CA)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects

Official Title ^ICMJE

Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects

Brief Summary

Acute compartment syndrome (ACS) is a complication of lower leg trauma that occurs when the pressure inside the leg due to swelling exceeds the body's ability to provide blood to the muscle of the leg. This condition cuts off blood flow to the leg. Left untreated, the condition can result in devastating consequences including complete loss of function of the lower extremity or amputation. Near-infrared spectroscopy (NIRS)-based tissue perfusion monitors are a non-invasive means of continuously monitoring the amount of oxygen in the tissues of an injured extremity. The device utilizes harmless red light to detect the proportion of hemoglobin saturated with oxygen up to 3 cm below the skin surface. The purpose of this study will be to launch the first stages of validation of this device as a diagnostic tool for compartment syndrome, by observing this device in uninjured subjects.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Other
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Uninjured volunteers will be recruited from a pool of uninjured individuals at the principle investigator's practice. Participation will be completely volutnary

Condition ^ICMJE

Acute Compartment Syndrome

Intervention ^ICMJE

Other: Shaving

Male patients will have the leg hair under each sensor site shaved, using an electric razor, and near infrared spectroscopy monitored for an additional 15 minutes

Study Groups/Cohorts

Controls

Uninjured volunteers

Intervention: Other: Shaving

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2017

Primary Completion Date

August 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

over 18 years old

Exclusion Criteria:

any current traumatic lower or upper extremity injury
unwilling or unable to provide written informed consent
history of any anatomy-altering injury or procedure to the upper or lower extremity

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01284023

Other Study ID Numbers ^ICMJE

NIRS-02

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

J&M Shuler

Study Sponsor ^ICMJE

J&M Shuler

Collaborators ^ICMJE

Nonin Medical, Inc

Investigators ^ICMJE

Principal Investigator:

Michael Shuler, MD

Athens Orthopedic Clinic, PA

PRS Account

J&M Shuler

Verification Date

March 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top