Effects of Hemodynamic Monitoring Using the ImaCor Single Use Transesophageal Echocardiography Probe in Critically Ill Patients

Summary

Hemodynamic management of critically ill patients is a constant challenge in the intensive care unit (ICU). Commonly used monitoring parameters to guide hemodynamic management generally consist of measurements of pressures (systemic and pulmonary artery pressures, cardiac filling pressures) and flow (cardiac output measurements using a thermodilution method). However, cardiac filling pressures and flow data have known limitations and might not accurately represent cardiac preload and contractility. Hemodynamic management of critically ill patients based on these parameters might therefore not be optimal and delay stabilisation of the patient, leading to negative outcomes and increased use of resources.

Visualization of the heart using echocardiography offers the advantage of direct measurement of cardiac volumes and systolic function. Echocardiography has been established as a tool to evaluate the causes of hemodynamic instability in ICU patients by the visualization of cardiac chambers, valves and pericardium and cardiac functional abnormalities. A repeated echocardiographic assessment could potentially provide useful additional information resulting in more rapid resolution of hemodynamic instability. Using conventional TTE and TEE, however, limits the feasibility of such an approach due to a lack of time and availability of appropriately trained staff.

In recently published studies the feasibility of hemodynamic monitoring and safety of hTEE was demonstrated. In the context of a prospective quality review assessment, the investigators showed that the echocardiographic examinations using hTEE were of sufficient quality in a majority of examined ICU patients and that the inter-rater reliability between the intensivists and a trained cardiologist was substantial. However, as of yet studies assessing the impact of hemodynamic monitoring by hTEE on relevant patient outcomes are not available. Given the associated costs for the hTEE device and the ultrasound probes and the additional resource requirements for training and application, the efficacy and efficiency of hTEE monitoring in comparison to standard monitoring should be established.

Conditions

• Shock

Interventions

DEVICE

ImaCor PM

The ImaCor ClariTEE (hTEE) device is a transesophageal echocardiography system. It produces a single-plane two-dimensional image. The ImaCor probe is a 5.5 mm detachable probe; it can remain in situ for up to 72h and allows for reassessment of the patient's hemodynamic progress and the effect of selected interventions at any time. The probe is connected to a dedicated echocardiographic system which allows the for the recording of digital loops and performance of basic two-dimensional measurements. ImaCorPM subjects will receive echocardiography-guided hemodynamic management (hTEE) at the time of inclusion, at the time of occurrence of defined new organ system deterioration and/or at least every 4 hours during the first 72h after study inclusion or until one of the following events occurs: study primary endpoints reached, patient is extubated, withdrawal of active treatment.

DEVICE

ImaCor SM

The ImaCor ClariTEE (hTEE) device is a transesophageal echocardiography system. It produces a single-plane two-dimensional image. The ImaCor probe is a 5.5 mm detachable probe; it can remain in situ for up to 72h and allows for reassessment of the patient's hemodynamic progress and the effect of selected interventions at any time. The probe is connected to a dedicated echocardiographic system which allows the for the recording of digital loops and performance of basic two-dimensional measurements. ImaCorSM subjects will receive echocardiography-guided hemodynamic management (hTEE) at the time of inclusion, follow-up assessment intervals are at the discretion of the treating physician for the first 72h after study inclusion. hTEE monitoring is discontinued if one of the following events occurs: study primary endpoints reached, patient is extubated, withdrawal of active treatment.

OTHER

Control PM

Group Control protocolized monitoring (ControlPM) will receive any hemodynamic monitoring of choice of the treating physician except ImaCor. Protocolized hemodynamic assessments will be performed at the time of inclusion, at the time of occurrence of defined new organ system deterioration or at least every 4 hours for the first 72h after study inclusion. Protocolized monitoring is discontinued if one of the following events occurs: study primary endpoints reached, patient is extubated, withdrawal of active treatment.

OTHER

Control SM

Group Control standard monitoring (ControlSM) will receive any hemodynamic monitoring of choice of the treating physician except ImaCor. Protocolized hemodynamic assessments will be performed at the time of inclusion, follow-up measurement intervals are at the discretion of the treating physician for the first 72h. Data collection from standard monitoring is discontinued if one of the following events occurs: study primary endpoints reached, patient is extubated, withdrawal of active treatment.

Sponsors & Collaborators

• ImaCor, Inc.

  collaborator INDUSTRY

• Insel Gruppe AG, University Hospital Bern

  lead OTHER

Principal Investigators

• Tobias M Merz, PD Dr. med. · Dep. of Intensive Care Medicine, Bern University Hospital

• Jukka Takala, Prof. Dr. med. · Dep. of Intensive Care Medicine, Bern University Hospital

• Stephan M Jakob, Prof. Dr. med. · Dep. of Intensive Care Medicine, Bern University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2017-10-19

Completion

2018-05-01

Countries

• Switzerland

Study Locations