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

Completed
Conditions
10007593
10047079
Leg ischemia / Limb hypoperfusion
Registration Number
NL-OMON54306
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
43
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

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

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>During surgery the tissue oxygen saturation, mitoPO2 and microcirculatory blood<br /><br>velocity will be measured continuously in the cannulated and non-cannulated<br /><br>limb.<br /><br>The main study parameter is the difference in mitoPO2 levels between the<br /><br>cannulated and non-cannulated leg and the difference in RBV measurements<br /><br>between these limbs, during cannulation, five minutes before end of CPB. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Difference in mitoPO2 levels between the cannulated and non-cannulated leg<br /><br>during the other flow alternating moments (before cannulation, start CPB, extra<br /><br>leg canula in case of ischaemia, end of CPB and after decannulation).<br /><br>- Difference in RBV measurements between the cannulated and non-cannulated leg<br /><br>during the other flow alternating moments (before cannulation, start CPB, extra<br /><br>leg canula in case of ischaemia, end of CPB and after decannulation).<br /><br>- Difference in response time of mitoPO2 and StO2.<br /><br>- Difference in response time of RBV and StO2.<br /><br>- Temperature (C) difference in both legs, as measured with the COMET probe.<br /><br>- Mean difference in flow as measured by the DLS sensor at the tube of the CPB<br /><br>pump and the flow of the CPB system</p><br>
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