NCT02639468

Brief Summary

Evaluation of electrical impedance tomography to non-invasively monitor stroke volume when compared to reference measurements performed via right heart thermodilution

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

December 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 24, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

December 17, 2015

Last Update Submit

November 26, 2018

Conditions

Stroke Volume

Outcome Measures

Primary Outcomes (1)

  • Correlation of stroke volume values measured via pulmonary catheter compared to EIT-derived stroke volume estimates.

    12 months

Study Arms (1)

Tomographie par impédance électrique

EXPERIMENTAL

Tomographie par impédance électrique

Device: Stroke Volume estimation using electrical impedance tomography

Interventions

Stroke Volume estimation using electrical impedance tomographyDEVICE
Tomographie par impédance électrique

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing cardiac surgery which requires placement of pulmonary catheter
  • Patients with right heart catheterization for diagnostic or therapeutic reasons

You may not qualify if:

  • Patient unable to understand the study
  • Patient unable to provide written consent or refusing his/her participation
  • Patient suffering from a severe valvular insufficiency
  • Patient allergic to ECG electrodes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV

Lausanne, 1011, Switzerland

Location

Study Design

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

Study Record Dates

First Submitted

December 17, 2015

First Posted

December 24, 2015

Study Start

April 1, 2016

Primary Completion

January 12, 2018

Study Completion

January 12, 2018

Last Updated

November 27, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)