Measuring limb perfusion with Near Infrared Spectroscopy (NIRS), Cellular Oxygen METabolism (COMET) and Dynamic Light Scattering (DLS) during Minimally Invasive Cardiac Surgery (MICS)

Measuring limb perfusion with Near Infrared Spectroscopy (NIRS), Cellular Oxygen METabolism (COMET) and Dynamic Light Scattering (DLS) during Minimally Invasive Cardiac Surgery (MICS) - LP-MICS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54306

Enrollment

Registered

2021-05-07

Start date

2022-07-20

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leg ischemia / Limb hypoperfusion

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 18 years or older - Acceptable proficiency of the Dutch or English language - ASA 2-4 - Minimally invasive cardiac surgery requiring cardiopulmonary bypass

Exclusion criteria

Exclusion criteria: - Absence of written informed consent - Presence of mitochondrial disease - Pregnancy/lactation - Emergency surgery - Patients with skin laesions on the lower extremities which impede measurements

Design outcomes

Primary

Measure	Time frame
During surgery the tissue oxygen saturation, mitoPO2 and microcirculatory blood velocity will be measured continuously in the cannulated and non-cannulated limb. The main study parameter is the difference in mitoPO2 levels between the cannulated and non-cannulated leg and the difference in RBV measurements between these limbs, during cannulation, five minutes before end of CPB.	—

Secondary

Measure	Time frame
- Difference in mitoPO2 levels between the cannulated and non-cannulated leg during the other flow alternating moments (before cannulation, start CPB, extra leg canula in case of ischaemia, end of CPB and after decannulation). - Difference in RBV measurements between the cannulated and non-cannulated leg during the other flow alternating moments (before cannulation, start CPB, extra leg canula in case of ischaemia, end of CPB and after decannulation). - Difference in response time of mitoPO2 and StO2. - Difference in response time of RBV and StO2. - Temperature (C) difference in both legs, as measured with the COMET probe. - Mean difference in flow as measured by the DLS sensor at the tube of the CPB pump and the flow of the CPB system	—

Measure

Time frame

- Difference in mitoPO2 levels between the cannulated and non-cannulated leg during the other flow alternating moments (before cannulation, start CPB, extra leg canula in case of ischaemia, end of CPB and after decannulation). - Difference in RBV measurements between the cannulated and non-cannulated leg during the other flow alternating moments (before cannulation, start CPB, extra leg canula in case of ischaemia, end of CPB and after decannulation). - Difference in response time of mitoPO2 and StO2. - Difference in response time of RBV and StO2. - Temperature (C) difference in both legs, as measured with the COMET probe. - Mean difference in flow as measured by the DLS sensor at the tube of the CPB pump and the flow of the CPB system

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Countries

Netherlands

Outcome results