Spectroscopic Assessment of Tissue Oxygenation Changes During Vascular Surgery

NCT07786623 | Not Yet Recruiting

• 1 other identifier: SpC Vascular
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a single-center, observational study designed to collect tissue spectrometric data related to tissue oxygenation.

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Ischemia Vascular; Tissue Ischemia

Keywords

tissue oxygenation; cytochrome c oxidase; near-infrared spectroscopy; intraoperative monitoring; medical device

Outcome Measures

Primary Outcomes (1)

• Observe changes in skeletal muscle tissue oxygenation

  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.

  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)

Secondary Outcomes (1)

• Incidence of adverse events, adverse device effects, and device deficiencies

  From sensor placement during the operation until discharge from hospital (up to 30 days)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A Helsinki University Hospital patient scheduled for a vascular surgical operation.

You may qualify if:

• Adults, age of 18 - 90 years
• Scheduled for peripheral arterial bypass surgery.
• Scheduled for proximal arterial reconstruction.
• Ability and willingness to provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spectrocor: lead
• Helsinki University Central Hospital: collaborator

Related Publications (9)

• Keller A. Noninvasive tissue oximetry for flap monitoring: an initial study. J Reconstr Microsurg. 2007 May;23(4):189-97. doi: 10.1055/s-2007-974655.

  PMID: 17530610 BACKGROUND

• Keller A. A new diagnostic algorithm for early prediction of vascular compromise in 208 microsurgical flaps using tissue oxygen saturation measurements. Ann Plast Surg. 2009 May;62(5):538-43. doi: 10.1097/SAP.0b013e3181a47ce8.

  PMID: 19387157 BACKGROUND

• Steele MH. Three-year experience using near infrared spectroscopy tissue oximetry monitoring of free tissue transfers. Ann Plast Surg. 2011 May;66(5):540-5. doi: 10.1097/SAP.0b013e31820909f9.

  PMID: 21301288 BACKGROUND

• Chen Y, Shen Z, Shao Z, Yu P, Wu J. Free Flap Monitoring Using Near-Infrared Spectroscopy: A Systemic Review. Ann Plast Surg. 2016 May;76(5):590-7. doi: 10.1097/SAP.0000000000000430.

  PMID: 25664408 BACKGROUND

• Tran PC, DeBrock W, Lester ME, Hartman BC, Socas J, Hassanein AH. The False Positive Rate of Transcutaneous Tissue Oximetry Alarms in Microvascular Breast Reconstruction Rises after 24 Hours. J Reconstr Microsurg. 2021 Jun;37(5):453-557. doi: 10.1055/s-0040-1719048. Epub 2020 Oct 31.

  PMID: 33129214 BACKGROUND

• Ali J, Cody J, Maldonado Y, Ramakrishna H. Near-Infrared Spectroscopy (NIRS) for Cerebral and Tissue Oximetry: Analysis of Evolving Applications. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2758-2766. doi: 10.1053/j.jvca.2021.07.015. Epub 2021 Jul 10.

  PMID: 34362641 BACKGROUND

• Schanzer A, Hevelone N, Owens CD, Belkin M, Bandyk DF, Clowes AW, Moneta GL, Conte MS. Technical factors affecting autogenous vein graft failure: observations from a large multicenter trial. J Vasc Surg. 2007 Dec;46(6):1180-90; discussion 1190. doi: 10.1016/j.jvs.2007.08.033.

  PMID: 18154993 BACKGROUND

• Eiberg JP, Schroeder TV, Vogt KC, Secher NH. Near-infrared spectroscopy during peripheral vascular surgery. Cardiovasc Surg. 1997 Jun;5(3):304-8. doi: 10.1177/096721099700500309.

  PMID: 9293366 BACKGROUND

• Dubosq M, Goueffic Y, Duhamel A, Denies F, Dervaux B, Goyault G, Sobocinski J. Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial. Ann Vasc Surg. 2021 Jan;70:362-369. doi: 10.1016/j.avsg.2020.06.061. Epub 2020 Jul 4.

  PMID: 32634565 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Maarit Venermo, Professor

  Helsinki University Hospital (HUS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommi Pätilä, PhD

CONTACT

+358 440130770; tommi@spectrocor.com

Kalle Kotilahti

CONTACT

+358449016550; kalle@spectrocor.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2031
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share