ClinicalTrials.Veeva

Menu

Cardiac Output Measurement With NICCOMO and PiCCO Devices at Different PEEP Levels

M

Medical University of Gdansk

Status

Unknown

Conditions

Cardiovascular Diagnostic Techniques

Treatments

Device: PICCO
Device: NICCOMO

Study type

Observational

Funder types

Other

Identifiers

NCT02572739
GUMed-Wu-002

Details and patient eligibility

About

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.

Full 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).

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

haemodynamics measuring
Description:
those with already implemented PICCO device get impedance device (NICCOMO) attached
Treatment:
Device: PICCO
Device: NICCOMO

Trial contacts and locations

1

Loading...

Central trial contact

Magdalena A Wujtewicz; Radoslaw Owczuk

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems