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.
ID
Bron
Verkorte titel
Aandoening
Cardia Surgery
Congenital Hear Disease
Infants
TEE
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Clinical and diagnostic image quality.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Transesophageal Echography during Cardiac Surgery.
Onderzoeksproduct en/of interventie
TEE during Congenital Heart surgery.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Pediatric patients with body weight > 2,5 kg;
2. Open heart surgery;
3. Congentital heart defect.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Pediatric patients with body weight < = 2,5 kg.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1829 |
| NTR-old | NTR1939 |
| Ander register | MEC Erasmus MC : MEC 2009-247 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |