search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Evaluation of the multiplane Micro Transesophageal Echocardiographic Probe in infants.


- candidate number6288
- NTR NumberNTR1939
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-aug-2009
- Secondary IDsMEC 2009-247 MEC Erasmus MC
- Public TitleEvaluation of the multiplane Micro Transesophageal Echocardiographic Probe in infants.
- Scientific TitleEvaluation of the worlds smallest multiplane Micro Transesophageal Echocardiographic Probe in infants scheduled for Cardiac Surgery for Congenital Heart Disease.
- ACRONYMTEE Micro Probe
- hypothesisTo 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) studiedCongenital heart defects, Infants, Cardia Surgery, TEE
- Inclusion criteria1. Pediatric patients with body weight > 2,5 kg;
2. Open heart surgery;
3. Congentital heart defect.
- Exclusion criteriaPediatric patients with body weight < = 2,5 kg.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 9-jan-2009
- planned closingdate31-dec-2009
- Target number of participants40
- InterventionsTEE during Congenital Heart surgery.
- Primary outcomeClinical and diagnostic image quality.
- Secondary outcomeN/A
- TimepointsTransesophageal Echography during Cardiac Surgery.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES T. Scohy
- CONTACT for SCIENTIFIC QUERIES T. Scohy
- Sponsor/Initiator Philips Ultrasound Inc.
- Funding
(Source(s) of Monetary or Material Support)
Philips Ultrasound Inc.
- PublicationsN/A
- Brief summaryBackground:
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.
- Main changes (audit trail)
- RECORD7-aug-2009 - 11-okt-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl