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
|Condition or disease||Intervention/treatment|
|Cardiovascular Diagnostic Techniques||Device: PICCO Device: NICCOMO|
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).
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
those with already implemented PICCO device get impedance device (NICCOMO) attached
measurements based on thermodilution
measurements based on impedance
- 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
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
|Contact: Magdalena A Wujtewiczfirstname.lastname@example.org|
|Contact: Radoslaw Owczukemail@example.com|
|Medical University of Gdansk||Recruiting|
|Gdansk, Poland, 80-214|
|Contact: Magdalena A Wujtewicz +48583493357 firstname.lastname@example.org|
|Contact: Radoslaw Owczuk 605408140 email@example.com|
|Principal Investigator:||Magdalena Wujtewicz||Department of Ophthalmology, Medical University of Gdańsk|