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Cardiac Output Measurement With NICCOMO and PiCCO Devices at Different PEEP Levels

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ClinicalTrials.gov Identifier: NCT02572739
Recruitment Status : Recruiting
First Posted : October 9, 2015
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Magdalena Wujtewicz, Medical University of Gdansk

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.

Condition or disease Intervention/treatment
Cardiovascular Diagnostic Techniques Device: PICCO Device: NICCOMO

Detailed Description:

Echocardiography is performed prior to measurement to exclude patients with heart valve abnormalities.

Patients without spontaneous ventilation ( deeply unconscious, sedated or sedated and paralysed), ventilated with controlled mechanical ventilation mode with tidal volume 6-8 ml/ideal body weight, resulting in EtCO2 35-45 mmHg, with PiCCO catheters implemented have additionally NICCOMO device attached. Fraction of inspired oxygen (FiO2) is set to achieve saturation >96% at positive end expiratory pressure (PEEP) 0 cmH2O.

Measurement of cardiac output are performed on expiration at PEEP 0, 5, 10, 15 20 cmH2O and at optimal PEEP (obtained from P-V curve). Simultaneously CO value from impedance device is noted. Other haemodynamic parameters, calculated by both devices are also noted - stroke volume (SV), stroke volume variation (SVV), Cardiac index (CI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI).


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: 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
Study Start Date : May 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Group/Cohort Intervention/treatment
haemodynamics measuring
those with already implemented PICCO device get impedance device (NICCOMO) attached
Device: PICCO
measurements based on thermodilution

Device: NICCOMO
measurements based on impedance




Primary Outcome Measures :
  1. Numbers of measurements of haemodynamic parameters (CO, CI, SV, SVV, CI, SVR, SVRI) obtained with impedance, that differ from those obtained with thermodilution [ Time Frame: up to 90 minutes ]
    measurements taken with impedance and thermodilution simultaneously, at PEEP 0, 5, 10, 15, 20 and at optimal PEEP



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients treated in intensive therapy unit, mechanically ventilated, haemodynamics monitored with PiCCO technique
Criteria

Inclusion Criteria:

  • critically ill patients
  • patients on mechanical ventilation
  • circulatory insufficiency (present or in the past) monitored with with PiCCO device

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572739


Contacts
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Contact: Magdalena A Wujtewicz +48583493357 magwuj@gumed.edu.pl
Contact: Radoslaw Owczuk 605408140 r.owczuk@gumed.edu.pl

Locations
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Poland
Medical University of Gdansk Recruiting
Gdansk, Poland, 80-214
Contact: Magdalena A Wujtewicz    +48583493357    magwuj@gumed.edu.pl   
Contact: Radoslaw Owczuk    605408140    r.owczuk@gumed.edu.pl   
Sponsors and Collaborators
Medical University of Gdansk
Investigators
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Principal Investigator: Magdalena Wujtewicz Department of Ophthalmology, Medical University of Gdańsk

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Responsible Party: Magdalena Wujtewicz, assistant professor, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT02572739     History of Changes
Other Study ID Numbers: GUMed-Wu-002
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019