Focused TTE for Hemodynamic Instable High Risk Patients

Not Applicable

Completed

• Conditions: Hemodynamic Instability During Anesthesia; High Risk Surgery
• Interventions: Other: intraoperative TTE

• Registration Number: NCT01811914
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-15
• Primary Completion: 2013-11
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intraoperative TTE	intraoperative TTE	TTE if a hemodynamic instability occurs

Primary Outcome Measures

Name	Time	Method
Change of patients´ management	at time of anesthesia / surgery	Recordings of TTE findings influencing change of patient´s management in the operating theatre

Trial Locations

Locations (1)

University Hospital of Marburg, Department of Anesthesia; 🇩🇪 Marburg, Germany