Focused TTE for Hemodynamic Instable High Risk Patients

Hemodynamic Instability During Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811914
• Other study ID #: UKGMTTE4
• Status: Completed
• Phase: N/A
• First received: March 13, 2013
• Last updated: April 16, 2014
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodynamic Instability During Anesthesia
• High Risk Surgery

Intervention

Other:
• intraoperative TTE

Locations

Country	Name	City	State
Germany	University Hospital of Marburg, Department of Anesthesia	Marburg

Sponsors (2)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	Kerckhoff Heart Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of patients´ management	Recordings of TTE findings influencing change of patient´s management in the operating theatre	at time of anesthesia / surgery	No