Evaluation of Three Dimensional Echocardiography in Critical Care Medicine

NCT ID: NCT03270319

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-08-31

Brief Summary

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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

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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.

Conditions

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Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Bloch, MD

Role: PRINCIPAL_INVESTIGATOR

Department of intensive care medicine, Luzerner Kantonsspital

Locations

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Department for Intensive Care Medicine

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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16032016

Identifier Type: -

Identifier Source: org_study_id

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