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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

Tracking Information
First Submitted Date  ICMJE March 13, 2013
First Posted Date  ICMJE March 15, 2013
Last Update Posted Date April 17, 2014
Study Start Date  ICMJE March 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Focused TTE for Hemodynamic Instable High Risk Patients
Official Title  ICMJE Intraoperative Focused TTE - Impact on High Risk Patients´ Management in Hemodynamic Instabilities
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hemodynamic Instability During Anesthesia
  • High Risk Surgery
Intervention  ICMJE Other: intraoperative TTE
Other Names:
  • focused transthoracic echocardiography
  • focused TTE
  • intraoperative transthoracic echocardiography
Study Arms  ICMJE Experimental: intraoperative TTE
TTE if a hemodynamic instability occurs
Intervention: Other: intraoperative TTE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2013)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01811914
Other Study ID Numbers  ICMJE UKGMTTE4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Thomas Kratz, Philipps University Marburg Medical Center
Study Sponsor  ICMJE Philipps University Marburg Medical Center
Collaborators  ICMJE Kerckhoff Heart Center
Investigators  ICMJE
Principal Investigator: Thomas Kratz, MD Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany
PRS Account Philipps University Marburg Medical Center
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP