Evaluation of Three Dimensional Echocardiography in Critical Care Medicine

NCT03270319 | Terminated

• 1 other identifier: 16032016
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock

Keywords

Measurement of cardiac output

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Feasibility of right ventricular pressure volume loops

  through study completion, an average of 1 year

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department for Intensive Care Medicine

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Bloch, MD

  Department of intensive care medicine, Luzerner Kantonsspital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: September 1, 2017
• Study Start: May 1, 2016
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)