Peroperative assessment of the heart's microcirculation during coronary arterial bypass surgery (CABG) with incident dark filed imaging
ID
Source
Brief title
Condition
- Coronary artery disorders
- Decreased and nonspecific blood pressure disorders and shock
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Description of the microcirculation of the heart, with the Microvascular Flow
Index (MFI) as the main outcome
Secondary outcome
Perfused vessel density (PVD), propotion or perfused vessels (PPV), total
vessel density (TVD) and heterogeneity index (HI) are measurements that run in
addition to the MFI to quantify microcirculation. We also compare the
microcirculatory parameters with the macrocirculatory parameters such as blood
pressure, heart rate, heart lung machine parameters, amount of cardioplegia and
type. With a trans esophageal cardiac echo, cardiac output and stroke volume
will be calculated.
Background summary
Microvascular changes that may occur despite optimal macroscopic hemodynamic
parameters and adequate cardioplegia (CP) may play an important role in
postoperative recovery after cardiac surgery. The occurrence of postoperative
complications such as atrial fibrillation and cardiac damage measured by
troponin release may be predicted by how the heart's microcirculation behaves
after CP and cardiopulmonary bypass (CPB). The influence of blood pressure,
cardioplegic fluid, used CPB fluids, blood products and medication factors are
known, but their effect on the microcirculation of the heart itself not. All
efforts are aimed at providing maximum protection of the myocardium and
vascular endothelium during cardiac surgery, but there is no way to test it
immediately. With incident dark field imaging (IDF) we can immediately look at
the microcirculation of the heart at the moment it matters. The first goal of
our research is to do a feasibility study and validate IDF imaging for the
heart.
Study objective
Peroperative assessment of the heart's microcirculation during coronary
arterial bypass surgery (CABG) with incident dark filed imaging
Study design
A clinical, prospective, observational, pilot study
Study burden and risks
Our research group has currently performed 70 intraoperative measurements on
the intestine during gastrointestinal surgery. This has led to clear insights
and publications. None of the patients in these studies have experienced any
complication or any burden. The operating time is estimated to be 5-10 minutes
longer. The IDF is completely sterile and there is extensive experience in
sterile handeling in the meantime. By analogy, we do not expect any problems
with future measurements at heart.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
-Age 18 and older scheduled for elective cardiac artery bypass surgery with signed informed consent
visible fat-free and accessible right atrium of the heart
Exclusion criteria
Age < 18
No informed consent
No fat-free of accessible right atrium of the heart
Design
Recruitment
Medical products/devices used
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 | NL63556.100.17 |