Electric Impedance Tomography | NCT02639468

Studies
Electric Impedance Tomography

NCT02639468

Sponsor

CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Status

Terminated

Last Update Posted

Nov 27, 2018Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Stroke Volume

Interventions

Stroke Volume estimation using electrical impedance tomography

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

protocol not fully appropriate technical issues with EIT device

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Jan 12, 2018Actual

Completion Date

Jan 12, 2018Actual

First Submitted Date

Dec 17, 2015

First Submission Date that Met QC Criteria

Dec 21, 2015

First Posted Date

Dec 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2018

Last Update Posted Date

Nov 27, 2018Actual

Name	Class
Centre Hospitalier Universitaire Vaudois	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tomographie par impédance électrique	Experimental	Tomographie par impédance électrique	Device: Stroke Volume estimation using electrical impedance tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stroke Volume estimation using electrical impedance tomography	Device		Tomographie par impédance électrique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation of stroke volume values measured via pulmonary catheter compared to EIT-derived stroke volume estimates.		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHUV		Lausanne		1011	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided