Clinical trial NCT01811914: Focused TTE for Hemodynamic Instable High Risk Patients
Official title: Intraoperative Focused TTE - Impact on High Risk Patients´ Management in Hemodynamic Instabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability During Anesthesia
High Risk Surgery
Keywords: focused TTE
intraoperative TTE
transthoracic echocardiography
high risk non-cardiac surgery
hemodynamic instabilities
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Kerckhoff Heart Center
First posted: 2013-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change of patients´ management
timeFrame: at time of anesthesia / surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: University Hospital of Marburg, Department of Anesthesia
Study officials:
affiliation: Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany
name: Thomas Kratz, MD
role: PRINCIPAL_INVESTIGATOR
References: