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Lower Limb Tissue Oxygenation Using Near-infrared Spectroscopy During Hallux Valgus Operation (INVOHV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04533035
Recruitment Status : Completed
First Posted : August 31, 2020
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Anna Govenius, Kuopio University Hospital

Study Description
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Brief Summary:

In acute lower limb ischemia the main goal of the treatment is to restore the blood before irreversible damage to the soft tissues of the limb. Delays in identifying acute lower limb ischemia may lead to limb loss or lead to the loss of the patient. Situations in which the patient is unable to express symptoms of the acute lower limb ischemia, such as during general anesthesia, in intensive care, or immediately after vascular surgery, are challenging for medical staff to identify. A reliable, easy-to-use and non-invasive monitoring method is not yet in every day use. The aim of this study is to demonstrate that Near InfraRed Spectroscopy (NIRS) monitoring is such a monitoring method.

Tourniquet induced ischemia is often used in hallux valgus surgery because it offers a bloodless view of the anatomical structures. In our study we will measure the soft tissue perfusion (rSO2) of the lower limbs during the whole operation. The sensors based on near-infrared spectroscopy will be located to the tibial surface and will record the normal state before the start of the tourniquet, during the tourniquet and also in the recovery phase.

The hypothesis is that rSO2 decreases linearly as a function of time from the beginning of the tourniquet induced ischemia and the recovery time depends on the duration of the tourniquet. In our study the patients will be operated under a spinal anesthesia. We also hypothesise that rSO2 increases due to the induction of the spinal anesthesia. Our goal is to define the percentual decline of rSO2 that is significant for lower limb ischemia and also its time response to induction of ischemia.


Condition or disease
Lower Limb Ischemia

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lower Limb Tissue Oxygenation Using Near-infrared Spectroscopy During Hallux Valgus Operation
Actual Study Start Date : August 28, 2020
Actual Primary Completion Date : February 26, 2021
Actual Study Completion Date : February 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion

Groups and Cohorts
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Group/Cohort
Single cohort
30 patients undergoing hallux valgus surgery


Outcome Measures
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Primary Outcome Measures :
  1. The percentual decrease of the regional oxygen saturation in the lower limb 15 minutes after the tourniquet is applied. [ Time Frame: 15 minutes from tourniquet application ]
    50% decrease from baseline NIRS value in 15 minutes


Secondary Outcome Measures :
  1. The time that the regional oxygen saturation in the lower limb takes to recover after the tourniquet is released. [ Time Frame: From the moment tourniquet is released to the point that NIRS value reaches it's baseline or patient is mobilised in the recovery room, whichever came first, assessed up to two hours. ]
    The time to NIRS value to reach baseline value after tourniquet is released

  2. The percentual increase of the regional oxygen saturation in the lower limbs due to the induction of a spinal anesthesia. [ Time Frame: 30 minutes from induction of spinal anesthesia ]
    10% increase in NIRS value after 30 minutes after spinal anesthesia induction


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Operative hallux valgus patients in Kuopio University Hospital.
Criteria

Inclusion Criteria:

  • Patient understands the meaning of the study and related measures.
  • Patient gives his or her written informed consent.
  • A tourniquet is used.
  • The procedure is performed under spinal anesthesia.
  • Body mass index under 40.

Exclusion Criteria:

  • Patient belongs to any of the following special groups: disabled people, minor, pregnant or breast feeding women, convicts, forensic psychiatric patients.
  • Previous lower limb vascular surgery.
  • Previous lower limb deep vein thrombosis.
  • Previously performed tibial fasciotomies.
  • Any another reason why the researcher considers that the patient is not suitable for the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533035


Locations
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Finland
Kuopio University Hospital
Kuopio, Finland, 70100
Sponsors and Collaborators
Kuopio University Hospital
Investigators
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Study Director: Kimmo Mäkinen, docent Kuopio University Hospital
Principal Investigator: Anna H Govenius, MD Kuopio University Hospital
More Information
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Responsible Party: Anna Govenius, Specialist in cardiothoracic surgery, MD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT04533035    
Other Study ID Numbers: 5101143
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Govenius, Kuopio University Hospital:
NIRS Spectroscopy
Lower Limb
Ischemia
Adults
Additional relevant MeSH terms:
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Hallux Valgus
Ischemia
Pathologic Processes
Foot Deformities
Musculoskeletal Diseases