Clinical Trials Directory

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UnknownNCT02572739

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

Status
Unknown
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Medical University of Gdansk · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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).

Conditions

Interventions

TypeNameDescription
DEVICEPICCOmeasurements based on thermodilution
DEVICENICCOMOmeasurements based on impedance

Timeline

Start date
2014-05-01
Primary completion
2020-12-01
Completion
2021-03-01
First posted
2015-10-09
Last updated
2020-04-13

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT02572739. Inclusion in this directory is not an endorsement.