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

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

Study Overview

• Status: Terminated
• Conditions: Shock

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 Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department for Intensive Care Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult intensive care patients treated in our intensive care unit with current hemodynamic unstable condition.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

ICU patient; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of stroke volume measurement with three dimensional echocardiography to stroke volume measurement by thermodilution	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.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of right ventricular pressure volume loops	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.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Andreas Bloch, MD, Department of intensive care medicine, Luzerner Kantonsspital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Measurement of cardiac output
• Other Study ID Numbers: 16032016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No