Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| DEVICE | PICCO | measurements based on thermodilution |
| DEVICE | NICCOMO | measurements 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.