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

NCT02048566 | Completed

• 1 other identifier: 174/13
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Echocardiography, Transesophageal; Monitoring, Physiologic; Shock

Outcome Measures

Primary Outcomes (1)

• Time to resolution of hemodynamic instability as defined by systemic mean blood pressure > 60mmHg

  At least 4 hours after discontinuation of vasopressors or inotropes

Secondary Outcomes (5)

• Length of time with need for organ support (mechanical ventilation, renal-replacement therapy)

  End of study, expected to be up to 24 weeks

• Length of stay in the ICU

  End of study, expected to be up to 24 weeks

• Length of stay in the hospital

  End of study, expected to be on average 1 year (or until death)

• Signs of hypoperfusion or organ dysfunction (Capillary refill time, urinary output, blood lactate levels)

  72 hours

• Use of conventional hemodynamic monitoring (PA catheter, CVP)

  72 hours

Study Arms (4)

hTEEPM

EXPERIMENTAL

Group hTEE protocolled monitoring (hTEEPM) will receive echocardiography-guided hemodynamic management (hTEE) at the time of inclusion, at the time of occurrence of defined new organ system deterioration (see below) 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 PM

hTEESM

EXPERIMENTAL

Group hTEE standard monitoring (hTEESM) 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. A follow up assessment is defined as any assessment that leads to significant changes in hemodynamic management in which case an hTEE assessment has to be performed. hTEE monitoring is discontinued if one of the following events occurs: study primary endpoints reached, patient is extubated, withdrawal of active treatment.

Device: ImaCor SM

ControlPM

ACTIVE COMPARATOR

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 PM

ControlSM

ACTIVE COMPARATOR

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 after study inclusion. A follow up assessment is defined as any assessment that leads to significant changes in hemodynamic management. 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.

Other: Control SM

Interventions

ImaCor PM DEVICE

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.

hTEEPM

ImaCor SM DEVICE

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.

hTEESM

Control PM OTHER

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.

ControlPM

Control SM OTHER

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.

ControlSM

Eligibility Criteria

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

You may qualify if:

• years of age or older AND
• Mechanical ventilation AND
• Systemic mean blood pressure \< 60 mmHg (or \< 80 mmHg if the patient has baseline hypertension) for more than 30 minutes despite adequate fluid resuscitation (minimum of 20 ml/kg crystalloids) OR
• Maintaining the systemic mean blood pressure \> 60 mmHg requires any dose of vasopressors or inotropes AND at least one of the following:
• Capillary refilling time three seconds or longer
• Lactate \>2 mmol/L
• Urine output \<0.5 mL/kg for at least one hour
• Written informed consent

You may not qualify if:

• Unrepaired tracheoesophageal fistula
• History of prior esophageal or gastric surgery precluding the use of TEE
• Esophageal obstruction or stricture
• Esophageal varices or diverticulum
• Esophageal or gastric perforation
• Gastric or esophageal bleeding
• Vascular ring, aortic arch anomaly with or without airway compromise
• Recent oropharyngeal surgery
• Severe coagulopathy (defined as thrombocyte count less than 30x10e9/l or INR \> 3)
• Cervical spine injury or anomaly
• Elective ICU admission after elective surgery
• Use of cardiac assist devices
• Use of extra-corporeal membrane oxygenation

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• ImaCor, Inc.: collaborator

Study Sites (1)

Dep. of Intensive Care Medicine, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (7)

• Vignon P, Mentec H, Terre S, Gastinne H, Gueret P, Lemaire F. Diagnostic accuracy and therapeutic impact of transthoracic and transesophageal echocardiography in mechanically ventilated patients in the ICU. Chest. 1994 Dec;106(6):1829-34. doi: 10.1378/chest.106.6.1829.

  PMID: 7988209 BACKGROUND

• Jensen MB, Sloth E, Larsen KM, Schmidt MB. Transthoracic echocardiography for cardiopulmonary monitoring in intensive care. Eur J Anaesthesiol. 2004 Sep;21(9):700-7. doi: 10.1017/s0265021504009068.

  PMID: 15595582 BACKGROUND

• Au SM, Vieillard-Baron A. Bedside echocardiography in critically ill patients: a true hemodynamic monitoring tool. J Clin Monit Comput. 2012 Oct;26(5):355-60. doi: 10.1007/s10877-012-9385-6. Epub 2012 Jul 27.

  PMID: 22836724 BACKGROUND

• Vieillard-Baron A, Slama M, Mayo P, Charron C, Amiel JB, Esterez C, Leleu F, Repesse X, Vignon P. A pilot study on safety and clinical utility of a single-use 72-hour indwelling transesophageal echocardiography probe. Intensive Care Med. 2013 Apr;39(4):629-35. doi: 10.1007/s00134-012-2797-4. Epub 2013 Jan 4.

  PMID: 23287876 BACKGROUND

• Cioccari L, Baur HR, Berger D, Wiegand J, Takala J, Merz TM. Hemodynamic assessment of critically ill patients using a miniaturized transesophageal echocardiography probe. Crit Care. 2013 Mar 27;17(3):R121. doi: 10.1186/cc12793.

  PMID: 23786797 BACKGROUND

• Merz TM, Cioccari L, Frey PM, Bloch A, Berger D, Zante B, Jakob SM, Takala J. Continual hemodynamic monitoring with a single-use transesophageal echocardiography probe in critically ill patients with shock: a randomized controlled clinical trial. Intensive Care Med. 2019 Aug;45(8):1093-1102. doi: 10.1007/s00134-019-05670-6. Epub 2019 Jul 4.

  PMID: 31273416 DERIVED

• Cioccari L, Zante B, Bloch A, Berger D, Limacher A, Jakob SM, Takala J, Merz TM. Effects of hemodynamic monitoring using a single-use transesophageal echocardiography probe in critically ill patients - study protocol for a randomized controlled trial. Trials. 2018 Jul 6;19(1):362. doi: 10.1186/s13063-018-2714-4.

  PMID: 29980233 DERIVED

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tobias M Merz, PD Dr. med.

  Dep. of Intensive Care Medicine, Bern University Hospital

  PRINCIPAL INVESTIGATOR

• Jukka Takala, Prof. Dr. med.

  Dep. of Intensive Care Medicine, Bern University Hospital

  STUDY CHAIR

• Stephan M Jakob, Prof. Dr. med.

  Dep. of Intensive Care Medicine, Bern University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 29, 2014
• Study Start: March 1, 2014
• Primary Completion: October 19, 2017
• Study Completion: May 1, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

CH (1)