Clinical trial NCT02572739: Cardiac Output Measurement With NICCOMO and PiCCO Devices at Different PEEP Levels
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diagnostic Techniques
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated in intensive therapy unit, mechanically ventilated, haemodynamics monitored with PiCCO technique

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).

Eligibility 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

Primary outcomes:
measure: Numbers of measurements of haemodynamic parameters (CO, CI, SV, SVV, CI, SVR, SVRI) obtained with impedance, that differ from those obtained with thermodilution
timeFrame: up to 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Medical University of Gdansk
Study officials:
affiliation: Department of Ophthalmology, Medical University of Gdańsk
name: Magdalena Wujtewicz
role: PRINCIPAL_INVESTIGATOR
References: