Cardiac Output Measurement With NICCOMO and PiCCO Devices at Different PEEP Levels
Assessment of Reliability of Cardiac Output Measurement Based on Impedance (NICCOMO) - Method of Noninvasive Cardiac Output Measurement, Compared to Transthoracic Thermodilution (PiCCO) at Different PEEP Levels
1 other identifier
observational
50
1 country
1
Brief Summary
Thermodilution cardiac output measurement is a reliable method, but it is an invasive one. PiCCO device requires cannulation of central vein and peripheral artery. Impedance method requires only attachment of special electrodes. Non-invasive methods are less accurate. Aim of study is to assess accuracy and reliability of impedance method ( using NICCOMO device) in comparison of thermodilution method ( using PiCCO device) at different PEEP levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2014
Longer than P75 for all trials
1 active site
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
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 23, 2015
CompletedFirst Posted
Study publicly available on registry
October 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedApril 13, 2020
April 1, 2020
6.6 years
September 23, 2015
April 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Numbers of measurements of haemodynamic parameters (CO, CI, SV, SVV, CI, SVR, SVRI) obtained with impedance, that differ from those obtained with thermodilution
measurements taken with impedance and thermodilution simultaneously, at PEEP 0, 5, 10, 15, 20 and at optimal PEEP
up to 90 minutes
Study Arms (1)
haemodynamics measuring
those with already implemented PICCO device get impedance device (NICCOMO) attached
Interventions
Eligibility Criteria
patients treated in intensive therapy unit, mechanically ventilated, haemodynamics monitored with PiCCO technique
You may qualify if:
- critically ill patients
- patients on mechanical ventilation
- circulatory insufficiency (present or in the past) monitored with with PiCCO device
You may not qualify if:
- morbid obesity,
- short neck,
- severe pneumonia,
- inability to NICCOMO electrodes attachment,
- massive tissue oedema,
- non-sinus cardiac rhythm,
- tachycardia,
- low cardiac output,
- septic shock,
- heart valve pathologies,
- severe atherosclerosis,
- aortic prosthesis,
- severe hypertension,
- extremes of height and weight,
- intraaortic pump
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Gdansk
Gdansk, 80-214, Poland
Study Officials
- PRINCIPAL INVESTIGATOR
Magdalena Wujtewicz
Department of Ophthalmology, Medical University of Gdańsk
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
September 23, 2015
First Posted
October 9, 2015
Study Start
May 1, 2014
Primary Completion
December 1, 2020
Study Completion
March 1, 2021
Last Updated
April 13, 2020
Record last verified: 2020-04