An observational study in Lower Limb Ischemia, sponsored by Kuopio University Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-02.
Sponsored by Kuopio University Hospital · Observational
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.
144 studies on the registry are indexed under Hallux Valgus; 31 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 35 observational studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Kuopio University Hospital is the lead sponsor of 132 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Operative hallux valgus patients in Kuopio University Hospital.
Exclusion Criteria:
30 patients undergoing hallux valgus surgery
The percentual decrease of the regional oxygen saturation in the lower limb 15 minutes after the tourniquet is applied.
50% decrease from baseline NIRS value in 15 minutes
Time frame: 15 minutes from tourniquet application
The time that the regional oxygen saturation in the lower limb takes to recover after the tourniquet is released.
The time to NIRS value to reach baseline value after 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 percentual increase of the regional oxygen saturation in the lower limbs due to the induction of a spinal anesthesia.
10% increase in NIRS value after 30 minutes after spinal anesthesia induction
Time frame: 30 minutes from induction of spinal anesthesia
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Kuopio University Hospital