Non-invasive Measurement of Central Hemodynamics by Electrical Impedance Tomography

Comparison of Availability for Prediction of Volume Responsiveness Clinical Trial

Official title:

Non-invasive Measurement of Central Hemodynamics and Heart-lung Interactions by Electrical Impedance Tomography

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01412970
• Other study ID #: DFG3171_2-1
• Status: Withdrawn
• Phase: N/A
• Start date: July 2016
• Est. completion date: March 2017

Study information

• Verified date: August 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the ability to measure central hemodynamics and heart-lung interactions non-invasively by electrical impedance tomography and compare it to clinically established hemodynamic monitoring.

Description:

The purpose of this study is to evaluate the ability to measure central hemodynamics and heart-lung interactions non-invasively by electrical impedance tomography and compare it to clinically established hemodynamic monitoring.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• Indication for advanced invasive hemodynamic monitoring due to operative procedure

• Necessity of postoperative invasive ventilation

Exclusion Criteria:

• Age <18 years

• known affections cardiac function

• presence of cardiac arrhythmias

• contraindication for placement of central venous or femoral artery catheter

Related Conditions & MeSH terms

• Comparison of Availability for Prediction of Volume Responsiveness
• Comparison of Limits of Agreement for Invasive and Non-invasive Measurement of Stroke Volume Variation

Intervention

Other:
• volume loading
volume loading according to functional parameters of cardiac preload, i.e. stroke volume variations measured by arterial pulse contour analysis

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement, Oregon Health and Science University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Maisch S, Bohm SH, Solà J, Goepfert MS, Kubitz JC, Richter HP, Ridder J, Goetz AE, Reuter DA. Heart-lung interactions measured by electrical impedance tomography. Crit Care Med. 2011 Sep;39(9):2173-6. doi: 10.1097/CCM.0b013e3182227e65. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to assess volume responsiveness by electrical impedance tomography	Assessment of volume responsiveness by electrical impedance tomography in mechanically ventilated patients by measurement of stroke volume variations under stepwise volume loading	within 3 hrs after surgical procedure
Secondary	precision of estimation of non invasive measurement of stroke volume variation	precision of estimation of non invasive measurement of stroke volume variation by electrical impedance tomography in comparison to clinically established, invasive advanced hemodynamic monitoring devices	within 3 hours after surgery