This study examines the pulse conductance of two oxygenators, that have been used in the clinic for more than 15 years now, and are regarded as clinically equivalent. For this study, it is sufficient to evaluate and compare postoperatively standard…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Puls conductance of the oxygenators Maquet Quadrox HMO 2000 and Terumo Capiox
SX18 during pulsatile perfusion with a heart-lung machine.
Secondary outcome
Blood damage, measured on the basis of standard measured/determined normalized
index of hemolysis during pulsatile perfusion with a heart-lung machine.
Background summary
During CABG heart surgery the patient's heart is stopped from beating. During
this heart arrest, the body circulation of the patient is maintained using a
heart-lung machine for perfusion. In the university hospital Maastricht
standard uses a pulsatile heart-lung machine, in other words, an artificial
pulsating blood flow. Before the generated pulsatile blood flow is pumped to
the patient, the blood flow (pulse) flows through an artificial lung, the so
called oxygenator. Because of its mechanical properties (elasticity and
resistance) the oxygenator affects the pulse; the oxygenator dampens and
reduces the pulse.
That the oxygenator affects the pulsatile blood flow is a common known fact to
every clinician, but data (publications) in which the effect of the oxygenator
on the flow pulse is quantified has, as far as we know, not been published.
Also, the influence of the oxygenator during pulsatile perfusion on blood
damage has, as far as we know, not been studied yet.
Study objective
This study examines the pulse conductance of two oxygenators, that have been
used in the clinic for more than 15 years now, and are regarded as clinically
equivalent. For this study, it is sufficient to evaluate and compare
postoperatively standard recorded per-opative perfusion data . In addition, we
will be able to confirm previously found in vitro data on pulse conductance of
oxygenators. Moreover, next to these aspects, the standard recorded perfusion
data can be used to compare the two oxygenators on blood damage. This blood
damage can be determined using standard taken per-operativel blood samples.
Study design
Prospective controlled randomized observational study.
Study burden and risks
No additional risks compared to those with the standard procedure of CABG
surgery.
P. Debeyelaan 25
6229 HX Maastricht
Nederland
P. Debeyelaan 25
6229 HX Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
-Patients scheduled for elective CABG using a standard heart-lung machine with either a standard used Maquet Quadrox HMO 2000 oxygenator, or a standard clinically equivalent Terumo Capiox SX18 oxygenator, using standard pulsatile perfusion at the University Hospital Maastricht.
-Written informed consent.
Exclusion criteria
-All other patients that do not comply with the inclusion criteria given above, e.g. patients receiving valve surgery, or combined CABG and valve surgery.
-No written informed consent.
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 | NL22896.068.08 |
| Other | www.trialregister.nl, nummer nog onbekend |