Non-invasive Measurement of Central Hemodynamics by Electrical Impedance Tomography

NCT01412970 | Withdrawn

• 1 other identifier: DFG3171_2-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

hemodynamic monitoring; volume responsiveness; electrical impedance tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• precision of estimation of non invasive measurement of stroke volume variation

  within 3 hours after surgery

Study Arms (1)

study group

OTHER

comparison of ability to predict volume responsiveness and precision of measurement of stroke volume variation assessed by electrical impedance tomography in comparison to clinically established invasive hemodynamic monitoring devices, i.e. arterial pulse contour analysis during volume loading procedures

Other: volume loading

Interventions

volume loading OTHER

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

study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Indication for advanced invasive hemodynamic monitoring due to operative procedure
• Necessity of postoperative invasive ventilation

You may not qualify if:

• Age \<18 years
• known affections cardiac function
• presence of cardiac arrhythmias
• contraindication for placement of central venous or femoral artery catheter

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement: collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Related Publications (1)

• Maisch S, Bohm SH, Sola 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.

  PMID: 21666450 BACKGROUND

Study Officials

• Daniel A Reuter, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 9, 2011
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

DE (1)