Focused TTE for Hemodynamic Instable High Risk Patients

NCT ID: NCT01811914

Last Updated: 2014-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Hemodynamic Instability During Anesthesia High Risk Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intraoperative TTE

TTE if a hemodynamic instability occurs

Group Type EXPERIMENTAL

intraoperative TTE

Intervention Type OTHER

Interventions

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intraoperative TTE

Intervention Type OTHER

Other Intervention Names

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focused transthoracic echocardiography focused TTE intraoperative transthoracic echocardiography

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kerckhoff Heart Center

OTHER

Sponsor Role collaborator

Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Dr. Thomas Kratz

Dr. Thomas Kratz

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Kratz, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany

Locations

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University Hospital of Marburg, Department of Anesthesia

Marburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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UKGMTTE4

Identifier Type: -

Identifier Source: org_study_id

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