NCT01865994

Brief Summary

The purpose of this study is to determine the measuring accuracy of the truly non-invasive method estimated continuous cardiac output (esCCO) against the reference method transesophageal echocardiography in pediatric cardiac surgery. esCCO is calculated using the pulse wave transit time, which is defined as the time between the R-wave of the ECG and the 30% increase of the differentiated pulseoximetry waveform.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

1.1 years

First QC Date

May 27, 2013

Last Update Submit

December 2, 2014

Conditions

Cardiac Diseases Requiring Surgery

Keywords

Cardiac OutputesCCOTEEPediatric cardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Cardiac Output

    EsCCO™ measurements shall be compared to TEE cardiac output measurements at three given times: (1) before surgical intervention, (2) shortly after cardiopulmonary bypass and (3) after closure of the thorax

    Intraoperative

Study Arms (1)

Pediatric cardiac surgery

Children scheduled for elective cardiac surgery

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients (0-18 yrs) scheduled for elective cardiac surgery

You may qualify if:

  • written consent
  • children \<=18 years
  • elective cardiac surgery
  • Sinus rhythm

You may not qualify if:

  • no written consent
  • continuous severe cardiac arrhythmias
  • cardiac Pacemaker
  • intraaortal balloon pump
  • contraindications for TEE
  • persistent ductus arteriosus botalli

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg

Heidelberg, 69120, Germany

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2013

First Posted

May 31, 2013

Study Start

August 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

DE(1)