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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02572739
Enrollment
50
Registered
2015-10-09
Start date
2014-05-31
Completion date
2021-03-31
Last updated
2020-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diagnostic Techniques

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.

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).

Interventions

DEVICEPICCO

measurements based on thermodilution

DEVICENICCOMO

measurements based on impedance

Sponsors

Medical University of Gdansk
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Numbers of measurements of haemodynamic parameters (CO, CI, SV, SVV, CI, SVR, SVRI) obtained with impedance, that differ from those obtained with thermodilutionup to 90 minutesmeasurements taken with impedance and thermodilution simultaneously, at PEEP 0, 5, 10, 15, 20 and at optimal PEEP

Countries

Poland

Contacts

Primary ContactMagdalena A Wujtewicz
magwuj@gumed.edu.pl+48583493357
Backup ContactRadoslaw Owczuk
r.owczuk@gumed.edu.pl605408140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026