Ultrasonix ECHO research.

Evaluation 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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20113

Enrollment

Registered

2012-08-14

Start date

2012-08-09

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiplane TEE probe adults and infants Critical care Congenital cardiac surgery

Interventions

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 c

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
Validation of the mTEE8-3/5 and TEM8-3/10 echocardiography probes combined with the Ultrasonix SonixTouch ultrasound system.	—

Contacts

Public ContactA. Saet, van

Thorax Center Erasmus University Medical Center Rotterdam PO BOX 2040

a.vansaet@erasmusmc.nl+31 (0)6 12555235

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)