Microcirculatory Alteration by a Vascular Occlusion Test Using Near-infrared Spectroscopy in Pediatric Cardiac Surgery

Completed

• Conditions: Microcirculation

• Registration Number: NCT06191913
• Lead Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Brief Summary

Cardiopulmonary bypass cause microcirculatory alterations. Near infrared spectroscopic measurement of tissue oxygen saturation and vascular occlusion test are novel technologies for assessing the microcirculatory function of peripheral tissue specifically in patients undergoing cardiac surgery with cardiopulmonary bypass

Detailed Description

Cardiac surgery and cardiopulmonary bypass (CPB) procedures cause microcirculatory alterations, and microvascular alterations and the impairment of tissue oxygen saturation (StO2) after cardiac surgery with CPB have been associated with adverse patient outcomes. It has been shown that contact with foreign surfaces causes transient microcirculatory dysfunction and activation of the inflammatory and hemostatic systems and that tissue trauma and anesthesia also affect microcirculation. Although microcirculation is affected by surgery with CPB, monitoring of the microcirculatory function is still not part of routine practice. Continuous real-time monitoring may aid in the early detection of tissue malperfusion.

StO2 measurement using NIRS and vascular occlusion testing (VOT) are novel techniques for assessing the microcirculatory function of peripheral tissue, specifically in patients undergoing cardiac surgery with CPB. The level of StO2 is determined by the amount of oxygen delivered and consumed. The deoxygenation rate, minimum rSO2, and reoxygenation rate measured using VOT may indicate tissue perfusion, the local metabolic rate, the oxygen reserve, and microvascular reactivity. It has been shown that prolonged exposure to CPB is associated with abnormal vasomotor responses and end-organ dysfunction. Although the INVOS system is not commonly used for VOT in children undergoing cardiac surgery with CPB, we hypothesized that using this noninvasive method to measure StO2 would allow detection of the local metabolic rate and local tissue perfusion adequacy change and that StO2 changes would reflect the preexisting cardiovascular reserve.

Study Timeline

• Study Start: 2021-01-18
• Primary Completion: 2022-03-06
• Study Completion: 2022-03-11
• Status Verified: 2023-12
• Study First Submitted: 2023-12-20
• Study First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Elective cardiac surgery with CPB

Exclusion Criteria

• Skin and peripheral vascular disease,
• Taking medicine for vascular disease,
• Emergency procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dynamic changes in the StO2	during operation	The following VOT parameters were calculated: baseline StO2 (%), occlusion slope (%/min) from baseline until nadir, minimum StO2 (%), reperfusion slope (%/min) from the minimum value to the maximum value, reperfusion time (min) from cuff release to the maximum value, and maximum StO2 (%). VOT was performed five times: before induction of anesthesia (T1), after induction of anesthesia (T2), during the CPB with full flow (T3), after the termination of the CPB (T4), and after sternum closure (T5

Trial Locations

Locations (1)

Mustafa Emre Gurcu; 🇹🇷 Istanbul, Turkey