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

NCT04533035 | Completed

• 1 other identifier: 5101143
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

NIRS Spectroscopy; Lower Limb; Ischemia; Adults

Outcome Measures

Primary Outcomes (1)

• 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

  15 minutes from tourniquet application

Secondary Outcomes (2)

• The time that the regional oxygen saturation in the lower limb takes to recover after the tourniquet is released.

  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.

  30 minutes from induction of spinal anesthesia

Study Arms (1)

Single cohort

30 patients undergoing hallux valgus surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Operative hallux valgus patients in Kuopio University Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kuopio University Hospital: lead

Study Sites (1)

Kuopio University Hospital

Kuopio, 70100, Finland

Location

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kimmo Mäkinen, docent

  Kuopio University Hospital

  STUDY DIRECTOR

• Anna H Govenius, MD

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in cardiothoracic surgery, MD

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 31, 2020
• Study Start: August 28, 2020
• Primary Completion: February 26, 2021
• Study Completion: February 26, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-03

Locations

FI (1)