Clinical trial NCT03270319: Evaluation of Three Dimensional Echocardiography in Critical Care Medicine
Official title: Evaluation of Three Dimensional Echocardiography in Critical Care Medicine
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Shock
Keywords: Measurement of cardiac output
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult intensive care patients treated in our intensive care unit with current hemodynamic unstable condition.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of stroke volume measurement with three dimensional echocardiography to stroke volume measurement by thermodilution
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Feasibility of right ventricular pressure volume loops
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department for Intensive Care Medicine
Study officials:
affiliation: Department of intensive care medicine, Luzerner Kantonsspital
name: Andreas Bloch, MD
role: PRINCIPAL_INVESTIGATOR
References: