NCT01811914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

8 months

First QC Date

March 13, 2013

Last Update Submit

April 16, 2014

Conditions

Hemodynamic Instability During AnesthesiaHigh Risk Surgery

Keywords

focused TTEintraoperative TTEtransthoracic echocardiographyhigh risk non-cardiac surgeryhemodynamic instabilities

Outcome Measures

Primary Outcomes (1)

  • Change of patients´ management

    Recordings of TTE findings influencing change of patient´s management in the operating theatre

    at time of anesthesia / surgery

Study Arms (1)

intraoperative TTE

EXPERIMENTAL

TTE if a hemodynamic instability occurs

Other: intraoperative TTE

Interventions

intraoperative TTEOTHER
Also known as: focused transthoracic echocardiography, focused TTE, intraoperative transthoracic echocardiography
intraoperative TTE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +4 more criteria

You may not qualify if:

  • cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Marburg, Department of Anesthesia

Marburg, D-35033, Germany

Location

Study Officials

  • Thomas Kratz, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Thomas Kratz

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 15, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2013

Study Completion

March 1, 2014

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

DE(1)