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Ultrasonix ECHO research.


- candidate number13237
- NTR NumberNTR3580
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-aug-2012
- Secondary IDs2012-271 METC Erasmus MC
- Public TitleUltrasonix ECHO research.
- Scientific TitleEvaluation of the new multiplane transesophageal echocardiography probes TEM 8-3/10 and mTEE 8-3/5 combined with the Ultrasonix SonixTouch ultrasound system in infants and adults scheduled for (congenital) cardiac surgery and in the ICU.
- ACRONYMUltrasonix
- hypothesisTEE has proven to be an invaluable tool in evaluation and guiding treatment in both adult and paediatric patients in the operating room and in the ICU. In the ICU the development of smaller TEE probes has led to the trans-nasal introduction of these probes, promoting patient comfort and making longer term use feasible. There is a continuous effort to improve the quality of intra-operative and ICU TEE imaging.
- Healt Condition(s) or Problem(s) studiedAdults, Children, Critical care, Congenital cardiac surgery, Multiplane TEE probe
- Inclusion criteria1. Paediatric patients weighing more than 2,5 kg and less than 20 kg undergoing congenital cardiac surgery;
2. Adult patients undergoing (congenital) cardiac surgery;
3. Hemodynamically stable, adult patients undergoing therapeutic hypothermia after resuscitation due to circulatory arrest admitted to the Cardiac ICU.
- Exclusion criteria1. No informed consent;
2. Absolute contra-indications for TEE probe insertion:
A. Current pathologic conditions of the esophagus (stricture, obstruction, trauma, scleroderma, tumor, diverticulum, Mallory-Weiss tear, unrepaired tracheoesophageal fistula);
B. Recent (< 6 weeks) esophageal or gastric surgery;
C. Esophagectomy or esophagogastrectomy;
D. Active upper gastro-intestinal bleeding;
E. History of dysphagia;
F. Perforated hollow viscus;
G. Poor airway control;
H. Cervical spine injury;
I. Severe coagulopathy;
J. Oropharyngeal pathology.
3. For the patients requiring therapeutic hypothermia after resuscitation:
A. Known anatomical defects in the nasopharyngeal passages;
B. Therapeutic anti-coagulation;
C. Hemodynamic instability.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 9-aug-2012
- planned closingdate1-jul-2013
- Target number of participants15
- InterventionsClinical and diagnostic ability of the mTEE8-3/5 and TEM8-3/10 echocardiography probes combined with the Ultrasonix SonixTouch ultrasound system with the goal of providing validation of these probes combined with the Ultrasonix SonixTouch ultrasound system. TEE imaging will be done intra-operative during cardio-thoracic surgery or during ICU stay.
- Primary outcomeValidation of the mTEE8-3/5 and TEM8-3/10 echocardiography probes combined with the Ultrasonix SonixTouch ultrasound system.
- Secondary outcomeN/A
- Timepoints1. Intra-operative TEE imaging;
2. ICU TEE imaging.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. A. Saet, van
- CONTACT for SCIENTIFIC QUERIESDrs. A. Saet, van
- Sponsor/Initiator Erasmus Medical Center, Department of Cardio-thoracic Surgery
- Funding
(Source(s) of Monetary or Material Support)
Ultrasonix Medical Corporation
- PublicationsN/A
- Brief summaryBackground of the study:
TEE has proven to be an invaluable tool in evaluation and guiding treatment in both adult and paediatric patients in the operating room and in the ICU. In the ICU the development of smaller TEE probes has led to the trans-nasal introduction of these probes, promoting patient comfort and making longer term use feasible. There is a continuous effort to improve the quality of intra-operative and ICU TEE imaging.

Objective of the study:
To evaluate the clinical and diagnostic ability of the mTEE8-3/5 and TEM8-3/10 echocardiography probes combined with the Ultrasonix SonixTouch ultrasound system with the goal of providing validation of these probes combined with the Ultrasonix SonixTouch ultrasound system.

Study design:
Observational, monocenter study.

Study population:
Five paediatric and five adult patients undergoing (congenital) cardiac surgery at the Department of Cardiothoracic Surgery at the Erasmus MC and five hemodynamically stable patients requiring therapeutic hypothermia after resuscitation due to circulatory arrest admitted to the Cardiac ICU Erasmus MC will be included. Primary study parameters/outcome of the study: Validation of the mTEE8-3/5 and TEM8-3/10 echocardiography probes combined with the Ultrasonix SonixTouch ultrasound system.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
TEE is considered a safe procedure in both the pediatric and adult patient. The incidence of complications during performance of TEE in the operating room is about 1-3,2 % in the pediatric population and 0,2-1,2 % in the adult population. In the ICU a complication rate of 2,6 % has been reported. For the patients on whom TEE will be performed in the operating room there is no additional burden or risk involved in participating in this study, apart from the known burdens and risks associated with TEE. For the patients undergoing a trans-nasal TEE in the Cardiac ICU there is a small chance of short-lived epistaxis with spontaneous resolution. Pain on nasal passage is not expected in this patient group, since only patients under deep sedation will be included. The probe is inserted and removed under general anaesthesia or deep sedation. For participants in the study there are no direct benefits.
- Main changes (audit trail)
- RECORD14-aug-2012 - 8-sep-2012


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