Evaluation of Three Dimensional Echocardiography in Critical Care Medicine (3DICU)

Insel Gruppe AG, University Hospital Bern

Status: Terminated

Conditions: Shock

Study type: Observational

Funder types: Other

Identifiers

NCT03270319

16032016

Details and patient eligibility

About

Comparison of volumetric measurements obtained by three dimensional echocardiography with measurements obtained by thermodilution using a pulmonary artery catheter in the intensive care unit.

Full description

Prospective, observational study evaluating three dimensional echocardiography for measuring hemodynamic variables versus the current gold standard (pulmonary artery catheter).

Critically ill patients with a severly compromised circulation due to a shock state with an advanced hemodynamic monitoring in place and the need for echocardiographic evaluation will be included.

While performing an echocardiography study stroke volume measurements using the bolus method for thermodilution will concomittantly be measured.

In case of insufficient image quality we are planning to use SonoVue echo contrast. Once the image quality has improved we will repeat the stroke volume measurements with the bolus thermodilution method while performing the echocardiography.

The acquired echocardiography loops will then be analysed and measured offline once deferred consent has been obtained. We will then compare the echocardiographic measurements with the measurement obtained by the pulmonary artery catheter (bolus method) - since this is the current reference method.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• advanced hemodynamic monitoring with pulmonary artery catheter and arterial catheter in place
• patient intubated or tracheostomy in place
• clinical indication for performing an echocardiography
• ongoing sedation requirement

Exclusion criteria

• Heart rhythm other than sinus rhythm or paced atrial rhythm
• Known allergy to sulphur-hexafluoride (SonoVue©)
• Artificial heart valves in place
• Any form of mechanical cardiac assist
• contraindication to performing a transesophageal echocardiography
• presence of significant cardiac valve regurgitation
• presence of an intracardiac shunt

Trial design

11 participants in 1 patient group

ICU patient

Description:

Critically ill patients in our adult intensive care unit with the following characteristics: * advanced hemodynamic monitoring in place including pulmonary artery catheter and arterial catheter * intubated or tracheostomy in place * echocardiography requested by the treating physician * intervention of interest: hemodynamic assessment done by echocardiography and thermodilution (pulmonary artery catheter)