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

April 10, 2020 updated by: Magdalena Wujtewicz, Medical University of Gdansk

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdansk, Poland, 80-214
        • Recruiting
        • Medical University of Gdańsk
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients treated in intensive therapy unit, mechanically ventilated, haemodynamics monitored with PiCCO technique

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
haemodynamics measuring
those with already implemented PICCO device get impedance device (NICCOMO) attached
Device: PICCO
measurements based on thermodilution
Device: NICCOMO
measurements based on impedance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Investigators

  • Principal Investigator: Magdalena Wujtewicz, Department of Ophthalmology, Medical University of Gdańsk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

October 7, 2015

First Posted (Estimate)

October 9, 2015

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • GUMed-Wu-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe