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Clinical Trials/NCT02572739
NCT02572739
Unknown
Not Applicable

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

Medical University of Gdansk1 site in 1 country50 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diagnostic Techniques
Sponsor
Medical University of Gdansk
Enrollment
50
Locations
1
Primary Endpoint
Numbers of measurements of haemodynamic parameters (CO, CI, SV, SVV, CI, SVR, SVRI) obtained with impedance, that differ from those obtained with thermodilution
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
March 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Magdalena Wujtewicz

assistant professor

Medical University of Gdansk

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,

Outcomes

Primary Outcomes

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

Study Sites (1)

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