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Focused TTE for Hemodynamic Instable High Risk Patients

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ClinicalTrials.gov Identifier: NCT01811914
Recruitment Status : Completed
First Posted : March 15, 2013
Last Update Posted : April 17, 2014
Sponsor:
Collaborator:
Kerckhoff Heart Center
Information provided by (Responsible Party):
Dr. Thomas Kratz, Philipps University Marburg Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hemodynamic Instability During Anesthesia High Risk Surgery Other: intraoperative TTE Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraoperative Focused TTE - Impact on High Risk Patients´ Management in Hemodynamic Instabilities
Study Start Date : March 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : March 2014

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811914


Locations
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Germany
University Hospital of Marburg, Department of Anesthesia
Marburg, Germany, D-35033
Sponsors and Collaborators
Philipps University Marburg Medical Center
Kerckhoff Heart Center
Investigators
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Principal Investigator: Thomas Kratz, MD Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany

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Responsible Party: Dr. Thomas Kratz, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT01811914     History of Changes
Other Study ID Numbers: UKGMTTE4
First Posted: March 15, 2013    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014
Keywords provided by Dr. Thomas Kratz, Philipps University Marburg Medical Center:
focused TTE
intraoperative TTE
transthoracic echocardiography
high risk non-cardiac surgery
hemodynamic instabilities