NCT03172689

Brief Summary

To compare the less invasive Oesophageal Doppler cardiac output Monitor (ODM) to the invasive (standard of care) Transpulmonary Thermodilution cardiac output monitor (TPTD) in children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 27, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 29, 2017

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

April 18, 2023

Status Verified

November 1, 2022

Enrollment Period

6.3 years

First QC Date

January 27, 2017

Last Update Submit

April 14, 2023

Conditions

Cardiac Output

Outcome Measures

Primary Outcomes (2)

  • cardiac output

    liter/m2/minute

    24 hours

  • stroke volume

    milliliters

    24 hours

Secondary Outcomes (2)

  • flow time corrected

    24 hours

  • stroke distance

    24 hours

Study Arms (1)

CardioQ

OTHER

CardioQ will be used as CO monitor simultaneously with the standard of care PiCCO CO monitor

Device: CardioQ

Interventions

CardioQDEVICE

comparison of cardiac output measurements between gold standard transpulmonary thermodilution (by PiCCO) versus an oesophageal doppler monitor (CardioQ) They will be used simultaneously

Also known as: PiCCO
CardioQ

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients aged 0 to 16 years with an indication for invasive CO monitoring (TPTD). Indication for invasive CO monitoring always implies intubation and sedation.
  • Signed informed consent

You may not qualify if:

  • Congenital or acquired cardiovascular diseases (intracardiac/extracardiac intrathoracic shunt
  • Cardiac valve diseases
  • Aortic arch anomalies
  • Tissue necrosis of oesophagus
  • Carcinoma of pharynx, larynx of oesophagus
  • Severe bleeding diatheses
  • Age \> 16 years
  • Weight \< 3.5 kg or \> 50 kg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud Univeristy Medical Center

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

Study Officials

  • Gert Jan Scheffer, prof. dr

    Radboud University Medical Center

    STUDY CHAIR

Central Study Contacts

Marieke Voet, drs

CONTACT

0031 24 3614406Marieke.Voet@radboudumc.nl

Joris Lemson, dr

CONTACT

0031 24 3653882Joris.Lemson@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: children with an clinical indication for cardiac output monitoring in ICU or OR
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2017

First Posted

June 1, 2017

Study Start

August 29, 2017

Primary Completion

December 1, 2023

Study Completion

February 1, 2024

Last Updated

April 18, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)