Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04533035
Study type Observational
Source Kuopio University Hospital
Contact
Status Completed
Phase
Start date August 28, 2020
Completion date February 26, 2021

See also
  Status Clinical Trial Phase
Withdrawn NCT02408991 - Use Art-assist and Neupogen to Treat Chronic Limb Ischemia Phase 4
Completed NCT02369809 - Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia Phase 4
Not yet recruiting NCT05569369 - Endovascular Management of Combined Common Femoral and Superficial Femoral Arteries Lesions N/A
Active, not recruiting NCT02856230 - An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK) Phase 2/Phase 3
Not yet recruiting NCT03295539 - Acute Limb Ischaemia (ALI) Management With 'Indigo' Mechanical Aspiration System N/A
Not yet recruiting NCT04277702 - Cysteinyl Leukotriene Antagonist in Atherosclerosis Inhibition in Patients After Endovascular Treatment Due to Peripheral Arterial Disease Phase 3
Not yet recruiting NCT06226844 - Can the BeatMove Device Help Patients With Obliterative Arterial Disease of the Lower Limbs?
Recruiting NCT02304588 - Stem Cell Therapy for Patients With Vascular Occlusive Diseases Such as Diabetic Foot Phase 1
Recruiting NCT01937416 - Autologous Bone Marrow Mononuclear Cells Therapy in Diabetic Lower Limb Ischemia Phase 1
Completed NCT05601349 - TeleEducation for Implementing a Clinical Practice Guideline For Amputees N/A
Active, not recruiting NCT01305863 - Feasibility Study of the TGI Adipose-derived Stromal Cell (ASC)-Coated ePTFE Vascular Graft N/A
Recruiting NCT06416644 - The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry) N/A
Completed NCT03910062 - Lower Limb Surveillance During VA-ECLS