Focused TTE for Hemodynamic Instable High Risk Patients

April 16, 2014 updated by: Dr. Thomas Kratz, Philipps University Marburg Medical Center

Intraoperative Focused TTE - Impact on High Risk Patients´ Management in Hemodynamic Instabilities

Focused transthoracic echocardiography (TTE) is a technique, which allows quick and non-invasive diagnosis and monitoring in hemodynamic instable patients. There are preliminary data supporting the hypothesis that TTE is feasible in the operating theatre.

The purpose of this study is to test the hypothesis that intraoperative focused TTE has an impact on high risk patients´ management when it is added to standard extended monitoring practices in hemodynamic instabilities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Focused TTE is en emerging matter in anesthesia, intensive care and emergency medicine. The value of intraoperative TTE is unclear. There are preliminary data that it is feasible For intraoperative transesophageal echocardiography (TEE) an impact on cardiac and non-cardiac surgery patients´ management has been shown.

Purpose of this study is to evaluate the application of focused TTE in patients with increased perioperative risk undergoing moderate to high risk surgery who become hemodynamic instable during anesthesia in the operating theatre.

When hemodynamic instability under anesthesia occurs focused TTE is conducted and the obtained diagnostic information are used for further patient management. Any change in management or therapy will be recorded.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Marburg, Germany, D-35033
        • University Hospital of Marburg, Department of Anesthesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • gender: male, female
  • Age ≥ 18 years

  • increased perioperative risk, at least one of the following:

    • coronary artery disease
    • congestive heart disease
    • insulin dependent diabetes mellitus
    • renal insufficiency, creatinine > 2,0 mg/dl
    • cerebrovascular disease
    • Sepsis

  • Procedure with at least moderate increased risk

    • intraperitoneal surgery
    • intrathoracal surgery
    • major orthopedic/traumatologic surgery
    • prostatic surgery
    • vascular surgery

  • Hemodynamic instability, at least one of the following:

    • Hypotension (systolic blood pressure < 80 mmHg or mean blood pressure <50 mmHg) and/or
    • Bradycardia < 45/min. orr Tachycardia > 120/min and/or
    • Cardiac index < 2,0 l/min/m2

Exclusion Criteria:

  • cardiac surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: intraoperative TTE
TTE if a hemodynamic instability occurs
Other: intraoperative TTE
Other Names:
  • focused transthoracic echocardiography
  • focused TTE
  • intraoperative transthoracic echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of patients´ management
Time Frame: at time of anesthesia / surgery
Recordings of TTE findings influencing change of patient´s management in the operating theatre
at time of anesthesia / surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philipps University Marburg Medical Center

Collaborators

Kerckhoff Heart Center

Investigators

  • Principal Investigator: Thomas Kratz, MD, Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

March 13, 2013

First Posted (ESTIMATE)

March 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 17, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UKGMTTE4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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