Kuopio University Hospital
Kuopio, 70100, Finland
NCT Number: NCT04533035
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Observational
Kuopio, 70100, Finland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 15 minutes from tourniquet application
50% decrease from baseline NIRS value in 15 minutes
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
Time frame: 30 minutes from induction of spinal anesthesia
10% increase in NIRS value after 30 minutes after spinal anesthesia induction
Kuopio University Hospital
Other
Acronym: INVOHV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02369809
Ischemia, Lower Limb Ischemia
Barnaul, Altayskiy Kray, Russia
View Trial DetailsNCT05601349
Clinical Practice Guidelines, Diabetes Mellitus
Medellín, Antioquia, Colombia
View Trial DetailsNCT03910062
Cardiac Arrest, Cardiogenic Shock
Nancy, France
View Trial DetailsNCT06226844
Artery Disease, Atheromatous
Nîmes, France
View Trial Details