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Focused TTE for Hemodynamic Instable High Risk Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01811914
Enrollment
50
Registered
2013-03-15
Start date
2013-03-31
Completion date
2014-03-31
Last updated
2014-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability During Anesthesia, High Risk Surgery

Keywords

focused TTE, intraoperative TTE, transthoracic echocardiography, high risk non-cardiac surgery, 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.

Interventions

OTHERintraoperative TTE

Sponsors

Kerckhoff Heart Center
CollaboratorOTHER
Philipps University Marburg
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of patients´ managementat time of anesthesia / surgeryRecordings of TTE findings influencing change of patient´s management in the operating theatre

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026