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

NCT ID: NCT04533035

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-28
• Study Completion Date: 2021-02-26

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.

Conditions

Lower Limb Ischemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single cohort

30 patients undergoing hallux valgus surgery

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuopio University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anna Govenius

Specialist in cardiothoracic surgery, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimmo Mäkinen, docent

Role: STUDY_DIRECTOR

Kuopio University Hospital

Anna H Govenius, MD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Locations

Kuopio University Hospital

Kuopio, , Finland

Countries

Finland

Other Identifiers

5101143

Identifier Type: -

Identifier Source: org_study_id