|- candidate number||6288|
|- NTR Number||NTR1939|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-aug-2009|
|- Secondary IDs||MEC 2009-247 MEC Erasmus MC|
|- Public Title||Evaluation of the multiplane Micro Transesophageal Echocardiographic Probe in infants.|
|- Scientific Title||Evaluation of the worlds smallest multiplane Micro Transesophageal Echocardiographic Probe in infants scheduled for Cardiac Surgery for Congenital Heart Disease.|
|- ACRONYM||TEE Micro Probe|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Congenital heart defects, Infants, Cardia Surgery, TEE|
|- 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.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||9-jan-2009|
|- planned closingdate||31-dec-2009|
|- Target number of participants||40|
|- Interventions||TEE during Congenital Heart surgery.|
|- Primary outcome||Clinical and diagnostic image quality.|
|- Secondary outcome||N/A|
|- Timepoints||Transesophageal Echography during Cardiac Surgery.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| T. Scohy|
|- CONTACT for SCIENTIFIC QUERIES|| T. Scohy|
|- Sponsor/Initiator ||Philips Ultrasound Inc.|
(Source(s) of Monetary or Material Support)
|Philips Ultrasound Inc.|
|- Brief 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.
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.
This study is designed as a prospective, single centre study.
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.
|- Main changes (audit trail)|
|- RECORD||7-aug-2009 - 11-okt-2009|