No registrations found.
ID
Source
Brief title
Health condition
Cardia Surgery
Congenital Hear Disease
Infants
TEE
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical and diagnostic image quality.
Secondary outcome
N/A
Background summary
Background:
In this study we want to evaluate the clinical and diagnostic ability of the micro TEE transducer, the smallest multiplane TEE in the world, in pediatric patients greater than 2.5 kg undergoing cardiac surgery to provide data on imaging quality.
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.
Design:
This study is designed as a prospective, single centre study.
Population:
The total number of patients expected to be enrolled in this trial is 42 (11). The study population consists of 40 consecutive pediatric patients greater than 2.5 kg scheduled for cardiac surgery for congenital heart disease.
Primary study parameters:
Clinical and diagnostic image quality.
Nature and extent of the burden and risks associated with participation:
No risks other than the standard risks of a TEE.
Study objective
To evaluate the clinical and diagnostic ability of the micro TEE transducer, 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
Transesophageal Echography during Cardiac Surgery.
Intervention
TEE during Congenital Heart surgery.
Inclusion criteria
1. Pediatric patients with body weight > 2,5 kg;
2. Open heart surgery;
3. Congentital heart defect.
Exclusion criteria
Pediatric patients with body weight < = 2,5 kg.
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 |
|---|---|
| NTR-new | NL1829 |
| NTR-old | NTR1939 |
| Other | MEC Erasmus MC : MEC 2009-247 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |