Chronic Limb-Threatening Ischemia, Ischemia Vascular, Peripheral Arterial Disease, Tissue Ischemia
Conditions
Keywords
tissue oxygenation, cytochrome c oxidase, near-infrared spectroscopy, intraoperative monitoring, medical device
Brief summary
This study is a single-center, observational study designed to collect tissue spectrometric data related to tissue oxygenation.
Detailed description
A total of 30 participants, aged 18 or older, undergoing planned elective primary vascular surgery will be recruited in this investigation to assess the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to monitor peripheral tissue oxygenation perioperatively. The investigation is designed as an open, uncontrolled observational study in which the primary goal is to assess the Monitor's ability, in combination with the Sensor, to monitor tissue oxygenation and safety in routine clinical practice, reflecting the real-world patient population and treatment scenarios. Therefore, no control participants are needed in this investigation.
Interventions
None listed
Sponsors
Spectrocor
Helsinki University Central Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adults, age of 18 - 90 years * Scheduled for peripheral arterial bypass surgery. * Scheduled for proximal arterial reconstruction. * Ability and willingness to provide informed consent.
Exclusion criteria
* Inability to provide informed consent * Considered a vulnerable person according to the Finnish Medical Research Act (488/1999), Chapter 2, Sections 7, 9, and 10, including retarded persons, pregnant women, nursing mothers, prisoners, and forensic patients. * A known history of severe allergic reaction to nickel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observe changes in skeletal muscle tissue oxygenation | From sensor placement prior to arterial clamping until restoration of limb blood circulation and completion of vascular reconstruction quality control (intraoperative period, approximately 2-6 hours) | To observe the changes in skeletal muscle tissue oxygenation (combined hemoglobin/myoglobin saturation, %) measured by the SpectroCor Monitoring System during arterial clamping and restoration of limb perfusion. Continuous spectroscopic measurement of combined hemoglobin and myoglobin oxygen saturation in skeletal muscle of the operated limb, recorded from a SpectroCor Sensor placed in the distal wound before any arterial clamping. Saturation values are time-stamped against intraoperative events affecting limb perfusion (proximal arterial clamping, unclamping, graft revision) and compared with paired arterial and venous blood gas samples obtained before clamping and after restoration of blood flow. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events, adverse device effects, and device deficiencies | From sensor placement during the operation until discharge from hospital (up to 30 days) | Number and proportion of participants experiencing at least one adverse event (AE), adverse device effect (ADE), serious adverse event (SAE), serious adverse device effect (SADE), or unanticipated serious adverse device effect (USADE), and the number of device deficiencies (DD) recorded. Events are recorded from the time of sensor placement until discharge from hospital and assessed for causal relationship to the investigational device by the investigator. Anticipated device-related events include topical bleeding at the sensor attachment site, local tissue reaction associated with tissue glue fixation, and local infection at the insertion site. |
Contacts
CONTACTTommi Pätilä, PhD
CONTACTKalle Kotilahti
PRINCIPAL_INVESTIGATORMaarit Venermo, Professor
Helsinki University Hospital (HUS)
Outcome results
None listed