Validation of CardioQ Versus PiCCO in Children | NCT03172689

Studies
Validation of CardioQ Versus PiCCO in Children

NCT03172689

Sponsor

Radboud University Medical Center

Status

Unknown status

Last Update Posted

Apr 18, 2023Actual

Enrollment

17Estimated

Phase

Not Applicable

Conditions

Cardiac Output

Interventions

CardioQ

Countries

Netherlands

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 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 29, 2017Actual

Primary Completion Date

Dec 1, 2023Estimated

Completion Date

Feb 1, 2024Estimated

First Submitted Date

Jan 27, 2017

First Submission Date that Met QC Criteria

May 29, 2017

First Posted Date

Jun 1, 2017Actual

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

Apr 14, 2023

Last Update Posted Date

Apr 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This is a validation study. The study period starts as soon as CMO approval is acquired and will end after inclusion of 17 patients. This study is designed to test the effectiveness of a non invasive ODM catheter compared to the invasive, gold standard, TPTD technique.

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

17Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CardioQ	Other	CardioQ will be used as CO monitor simultaneously with the standard of care PiCCO CO monitor	Device: CardioQ

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CardioQ	Device	comparison of cardiac output measurements between gold standard transpulmonary thermodilution (by PiCCO) versus an oesophageal doppler monitor (CardioQ) They will be used simultaneously

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cardiac output	liter/m2/minute	24 hours
stroke volume	milliliters	24 hours

Secondary Outcomes

Measure	Description	Time Frame
flow time corrected	seconds	24 hours
stroke distance	centimeters	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marieke Voet, drs	Contact	0031 24 3614406		Marieke.Voet@radboudumc.nl
Joris Lemson, dr	Contact	0031 24 3653882		Joris.Lemson@radboudumc.nl

Overall Officials

Name	Affiliation	Role
Gert Jan Scheffer, prof. dr	Radboud University Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud Univeristy Medical Center	Recruiting	Nijmegen	Gelderland	6500 HB	Netherlands

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