The primary objective of this study is to evaluate the impact of carbon dioxide field flooding on the quantitative intraoperative microembolic load of the brain during aortic arch surgery.A secondary objective is to evaluate any concomitant…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Vascular therapeutic procedures
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of cerebral microemboli counted on Transcranial Doppler ultrasound
recordings
Secondary outcome
Postoperative ischemic reactions in the brain assessed by diffusion-weighted
magnetic resonance imaging of the brain
Background summary
The presence of air emboli in open heart surgery implies an important risk for
postoperative neurological damage. Flooding the operative field with carbon
dioxide (CO2) has been used for displacing air from the thoracic cavity and
cardiac chambers. The theoretical value of this technique is that carbon
dioxide will displace air from the operative field because it is a heavier gas
and because carbon dioxide emboli, if they occur, are better tolerated than air
emboli.
Despite this impressive theoretical advantages, the use of carbon dioxide field
flooding is not widespread. Probably, this is due a disbelieve in this
technique because only small numbers of studies have tried to prove its
effectiveness. Moreover, a prospective randomised study using Transcranial
Doppler ultrasound (TCD) has never been done. With TCD the cerebral
microembolic load can be measured directly.
We hypothesize that the intraoperative cerebral embolic load can be reduced
dramatically with the use of intraoperative carbon dioxide field flooding. But
this has to be confirmed with intraoperative TCD.
Study objective
The primary objective of this study is to evaluate the impact of carbon dioxide
field flooding on the quantitative intraoperative microembolic load of the
brain during aortic arch surgery.
A secondary objective is to evaluate any concomitant difference in
postoperative ischemic reactions in the brain assessed by diffusion-weighted
MR-imaging (Magnetic Resonance Imaging).
Study design
Single-centre prospective randomzed double-blind clinical trial
Intervention
In one group carbon dioxide surgical field flooding is used intraoperatively
and in the other group not
Study burden and risks
No clear risks according to the use of intraoperative wound ventilation with
CO2 are known.
No blood samples are needed for this study.
No extra visits, physical examinations, questionnaires or diaries are necessary
for this study.
One extra MRI brain scan will be done.
We anticipate no physical and physiological discomfort associated with
participation.
Koekoekslaan 1
3435 CM Nieuwegein
NL
Koekoekslaan 1
3435 CM Nieuwegein
NL
Listed location countries
Age
Inclusion criteria
all patients accepted for elective surgery on the ascending aorta and aortic arch via median sternotomy
Exclusion criteria
- emergency operation (including type A dissection)
- patients with a difficult transtemporal acoustic ultrasound *bone window*
- patients with claustrophobia and therefore unwilling to have magnetic resonance brain imaging or that have other contra-indications for this investigation (pacemakers, etc.)
- patients with a more than 60% stenosis or occlusion of one or both carotid arteries
- intraoperative technical failure of TCD registration
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 |
|---|---|
| EudraCT | EUCTR2006-003660-65-NL |
| CCMO | NL11765.100.06 |