Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects
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ClinicalTrials.gov Identifier: NCT01284023 |
Recruitment Status
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Active, not recruiting
First Posted
: January 26, 2011
Last Update Posted
: March 17, 2017
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Sponsor:
J&M Shuler
Collaborator:
Nonin Medical, Inc
Information provided by (Responsible Party):
J&M Shuler
Tracking Information | ||||
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First Submitted Date | January 25, 2011 | |||
First Posted Date | January 26, 2011 | |||
Last Update Posted Date | March 17, 2017 | |||
Study Start Date | January 2011 | |||
Actual Primary Completion Date | August 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Near infrared spectroscopy [ Time Frame: 1 hour ] Uninjured subjects will lay supine and be monitored for two one hour periods, on separate days.
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Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT01284023 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects | |||
Official Title | 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 | Observational | |||
Study Design | Observational Model: Other Time Perspective: Cross-Sectional |
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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 | Acute Compartment Syndrome | |||
Intervention | 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 |
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Study Groups/Cohorts | Controls
Uninjured volunteers
Intervention: Other: Shaving |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Active, not recruiting | |||
Estimated Enrollment |
42 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | December 2017 | |||
Actual Primary Completion Date | August 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01284023 | |||
Other Study ID Numbers | NIRS-02 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | J&M Shuler | |||
Study Sponsor | J&M Shuler | |||
Collaborators | Nonin Medical, Inc | |||
Investigators |
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PRS Account | J&M Shuler | |||
Verification Date | March 2017 |