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Completed

NCT Number: NCT01811914

Focused TTE for Hemodynamic Instable High Risk Patients

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.

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Key information

Conditions

Hemodynamic Instability During Anesthesia High Risk Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Marburg, Department of Anesthesia

Marburg, D-35033, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intraoperative TTE

Other

Other names: focused transthoracic echocardiography, focused TTE, intraoperative transthoracic echocardiography

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • Kerckhoff Heart Center

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Mar 15, 2013
Registry last updated
Apr 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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