Evaluation of Three Dimensional Echocardiography in Critical Care Medicine

Terminated

• Conditions: Shock

• Registration Number: NCT03270319
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-03-17
• Study Start: 2016-05
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-01
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of stroke volume measurement with three dimensional echocardiography to stroke volume measurement by thermodilution	through study completion, an average of 1 year	The stroke volume of three to six heart beats will be measured after having performed an echocardiographic study. The stroke volume by thermodilution will be measured during the individual examination.

Secondary Outcome Measures

Name	Time	Method
Feasibility of right ventricular pressure volume loops	through study completion, an average of 1 year	Off-line analysis of pressure time curve for right ventricle using data from pulmonary artery catheter and volume time curve from echocardiographic data. Assessment of feasibility to combine these two curves to a pressure volume loop.

Trial Locations

Locations (1)

Department for Intensive Care Medicine; 🇨🇭 Bern, Switzerland