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Evaluation of Three Dimensional Echocardiography in Critical Care Medicine

Evaluation of Three Dimensional Echocardiography in Critical Care Medicine

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03270319
Acronym
3DICU
Enrollment
11
Registered
2017-09-01
Start date
2016-05-31
Completion date
2019-08-31
Last updated
2024-10-30

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

Conditions

Shock

Keywords

Measurement of cardiac output

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.

Interventions

None listed

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of stroke volume measurement with three dimensional echocardiography to stroke volume measurement by thermodilutionthrough study completion, an average of 1 yearThe 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

MeasureTime frameDescription
Feasibility of right ventricular pressure volume loopsthrough study completion, an average of 1 yearOff-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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026