Determine the difference in mitoPO2 in between the cannulated and non-cannulated and the difference in DLS red blood cell velocity (RBV) between the two legs, in patients undergoing a cardiopulmonary bypass (CPB) MICS with standard cannulation.
ID
Source
Brief title
Condition
- Cardiac therapeutic procedures
- Vascular injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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
Background summary
Minimally Invasive Cardiac Surgery (MICS) is a minimal access method for
cardiac surgery requiring cannulation of the femoral vein and artery instead of
central cannulation for cardiopulmonary bypass. The arterial cannula frequently
compromises the perfusion (decreased cellular oxygenation) of the cannulated
limb, requiring an additional distal leg cannula.
The current *golden standard* for detecting cellular ischemia is
near-infrared-based tissue oxygen saturation measurement (StO2, ForeSight
Elite) of both legs. A decline of 20% of the baseline StO2 or StO2 measurements
below 50% is defined as critical. The recently introduced Cellular Oxygen
METabolism (COMET) monitor (Photonics Healthcare) measures cutaneous
mitochondrial oxygen tension (mitoPO2) and oxygen consumption (MitoVO2) and can
detect cellular ischaemia very early. Moreover, dynamic light scattering (DLS)
sensors (Elfi-Tech Ltd.) enable measurement of the microcirculatory blood
velocity in order to investigate limb perfusion and can detect a decrease in
blood velocity. The hypothesis is that these two new techniques are able to
detect ischemia in the cannulated leg more reliably and earlier than the
currently available technique.
Study objective
Determine the difference in mitoPO2 in between the cannulated and
non-cannulated and the difference in DLS red blood cell velocity (RBV) between
the two legs, in patients undergoing a cardiopulmonary bypass (CPB) MICS with
standard cannulation.
Study design
Single centre, blinded, observational cohort study.
Study burden and risks
The intracellular oxygen measurement, using NIRS, is a non-invasive measurement
technique and does not lead to deviations from standard protocols. A discomfort
for the patient could be the aminolevulinic acid (ALA) containing-plaster, in
order to make the skin sensitive for light and causing transient irritation of
the skin, which is needed for the COMET measurement. This plaster is applied on
the skin on the evening before the scheduled surgery. The DLS sensor contains a
class 1 laser source and is safe for the human retina. The sensor will be
attached to the skin using double-sided adhesives, custom adhesive rings and/or
commercially available adhesive rings that are used for regular care
transcutaneous blood gas monitoring. Overall, the study comes with a negligible
risk and the burden is very low.
Dr. Molewaterplein 40
ROTTERDAM 3015GD
NL
Dr. Molewaterplein 40
ROTTERDAM 3015GD
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76108.078.21 |