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NCT01459341 Clinical Trial

Near Infrared Spectroscopy and Transcutaneous Oxygen Pressure in Critical Limb Ischemia Before and After Treatment

Critical Limb Ischemia Clinical Trial

— NIRS  

Official title:
Comparison of Near Infrared Spectroscopy (NIRS) and Transcutaneous Oxygen Pressure (TCPO2) Measurements in Critical Limb Ischemia (CLI) Patients After Invasive Treatment (Endovascular or Surgery)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01459341
Other study ID # CMC-11-0017 CTIL
Secondary ID NIRS-001-Carmel
Status Completed
Phase N/A
First received October 18, 2011
Last updated December 5, 2012
Start date July 2011
Est. completion date November 2012

Study information
Verified date December 2012
Source Carmel Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

Comparison of two non-invasive methods for measuring tissue oxygenation. One is Transcutaneous Oxygen Pressure (TCPO2) and the other is the new method of Near Infrared Spectroscopy (NIRS) - near infrared spectroscopy in patients with critical limb ischemia (CLI) undergoing invasive treatment (surgical or endovascular).

Description:

Comparison of two non-invasive methods for measuring tissue oxygenation. One is TCPO2 and the other is the new method of NIRS - near infrared spectroscopy in patients with critical limb ischemia (CLI) undergoing invasive treatment (surgical or endovascular).

The NIRS probe has been used to measure tissue oxygenation in the cerebral circulation up to now. While TCPO2 is the established method for measuring tissue oxygenation in patients with CLI to evaluate the potential for wound healing.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date November 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- 10 patients admitted to the vascular surgical department and undergoing invasive treatment (surgical or endovascular)

Exclusion Criteria:

- pregnancy allergy to iod advanced renal failure CCT<50 active peptic ulcer recent bleeding

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel department of vascular surgery, Carmel medical center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary tissue oxygenation the outcome will be assessed during the hospital stay up to a week No
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