In this study we want to evaluate the clinical and diagnostic ability of the micro TEE transducer (7.5 - 5.5 mm diameter tip, 18.5 mm length tip with a 5.2 mm diameter shaft) (Figure 1,2), the smallest multiplane TEE in the world, in pediatric…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
clinical and diagnostic image quality.
Secondary outcome
none
Background summary
The role of transesophageal echocardiography (TEE) during surgery for
congenital cardiac disease to define complex anatomical structures, functional
abnormalities, and to monitor hemodynamics is well established [1,1,2]. Until
1990, intraoperative evaluation of infants and children undergoing congenital
heart surgery was not feasible with TEE because probe sizes were too large [1].
It is not surprising that inability to pass the TEE probe and complications as
esophageal trauma, airway compromise, and aortic compression occur
predominantly in smaller children [3]. The subsequent development of
miniaturized single- and bi-plane probes (from 9 mm down to 3.3 mm diameter)
has generated a number of studies, which have demonstrated that TEE can be
performed safely in the pediatric population [4-6]. A multiplane TEE probe for
neonates and small children, which obtains images in several planes, is an
obvious advantage, certainly considering the complexity of the intracardiac
defects [7-9]
However, the use of a mini multiplane TEE probe (10.7 - 8.0 mm diameter tip
with a 7.4 mm diameter shaft) is still limited to children above the weight of
5 kg [10], until today the smallest available multiplane TEE probe on the
market.
In the Thoraxcentrum Rotterdam intaoperative TEE, with the Oldelft
Micromultiplane TEE (8.2 - 7 mm diameter tip, 24.0 mm length tip with a 5.2 mm
diameter shaft) (Oldelft, Delft, The Netherlands) connected to a Philips iE 33
ultrasound system (Philips, Andover, MA. USA) is since January 2006 standard
practice in all infants above a weight of 2.5 kg scheduled for cardiac surgery
for congenital heart disease [11].
In this study we want to evaluate the clinical and diagnostic ability of the
micro TEE transducer (7.5 - 5.5 mm diameter tip, 18.5 mm length tip with a 5.2
mm diameter shaft) (Figure 1,2), the smallest multiplane TEE in the world, in
pediatric patients greater than 2.5 kg undergoing cardiac surgery to provide
data on imaging quality.
Study objective
In this study we want to evaluate the clinical and diagnostic ability of the
micro TEE transducer (7.5 - 5.5 mm diameter tip, 18.5 mm length tip with a 5.2
mm diameter shaft) (Figure 1,2), the smallest multiplane TEE in the world, in
pediatric patients greater than 2.5 kg undergoing cardiac surgery to provide
data on imaging quality.
Study design
This study is designed as a prospective, single centre study.
Intervention
TEE during operation
Study burden and risks
No risks other than the standard risks of a TEE.
Philips Healthcare
3000 Minuteman Road, Andover, MA 018010-1099
USA
Philips Healthcare
3000 Minuteman Road, Andover, MA 018010-1099
USA
Listed location countries
Age
Inclusion criteria
Pediatric patients with body weight > 2,5 kg
Open heart surgery
Congentital heart defect
Exclusion criteria
Pediatric patients with body weight < = 2,5 kg
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 | NL27602.078.09 |