Skip to main content
MedPathMedPath Home
Clinical Trials/NCT03172689
NCT03172689
Recruiting
Not Applicable

Validation of an Ultrasound Oesophageal Doppler Cardiac Output Monitor (ODM+, CardioQ) Versus a Transpulmonary Thermodilution Cardiac Output Monitor (TPTD, PiCCO)

Radboud University Medical Center1 site in 1 country17 target enrollmentAugust 29, 2017
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsCardiac Output

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Output
Sponsor
Radboud University Medical Center
Enrollment
17
Locations
1
Primary Endpoint
cardiac output
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 29, 2017
End Date
February 1, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

cardiac output

Time Frame: 24 hours

liter/m2/minute

stroke volume

Time Frame: 24 hours

milliliters

Secondary Outcomes

  • stroke distance(24 hours)
  • flow time corrected(24 hours)

Study Sites (1)

Loading locations...

Similar Trials

Recruiting
Not Applicable
Validation of an Oesophageal Doppler Cardiac Output Monitor (ODM) versus a Transpulmonary Thermodilution Cardiac Output Monitor (PiCCO).cardiac output10011954
NL-OMON43157Radboud Universitair Medisch Centrum17
Recruiting
Not Applicable
Oesophageal Doppler compared to Plethysmographic Variability Index to Guide Perioperative Fluid Management for Cirrhotic Patients undergoing Liver ResectioDigestive System
PACTR201808140151322ational Liver Institute40
Completed
Not Applicable
A comparison of oesophageal Doppler with arterial pressure waveform derived cardiac output and stroke volume variation for the assessment of haemodynamic state in adult patients undergoing major surgery.Major surgery with significant blood lossHypovolemiaAnaesthesiology - Anaesthetics
ACTRN12609000407291Anaesthetic Department, St Vincent's Hospital39
Unknown
Not Applicable
USCOM For Assessing Patients With COPDChronic Obstructive Pulmonary Disease
NCT02329522Chinese University of Hong Kong200
Completed
Not Applicable
Comparison of ultrasonography of neck and stomach to detect air entry into stomach during start of general anaesthesia .Health Condition 1: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
CTRI/2019/10/021518Jawaharlal Institute of Postgraduate Medical Education and Research90