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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01459341
First received: October 18, 2011
Last updated: December 5, 2012
Last verified: December 2012

October 18, 2011
December 5, 2012
July 2011
September 2012   (final data collection date for primary outcome measure)
tissue oxygenation [ Time Frame: the outcome will be assessed during the hospital stay up to a week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01459341 on ClinicalTrials.gov Archive Site
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Near Infrared Spectroscopy and Transcutaneous Oxygen Pressure in Critical Limb Ischemia Before and After Treatment
Comparison of Near Infrared Spectroscopy (NIRS) and Transcutaneous Oxygen Pressure (TCPO2) Measurements in Critical Limb Ischemia (CLI) Patients After Invasive Treatment (Endovascular or Surgery)

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).

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

  • Peripheral Vascular Disease
  • Critical Limb Ischemia
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
November 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01459341
CMC-11-0017 CTIL, NIRS-001-Carmel
Yes
Carmel Medical Center
Carmel Medical Center
Not Provided
Principal Investigator: Dallit Mannheim, MD Carmel Medical Center
Carmel Medical Center
December 2012

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