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

• Conditions: Cardiovascular Diagnostic Techniques
• Interventions: Device: PICCO; Device: NICCOMO

• Registration Number: NCT02572739
• Lead Sponsor: Medical University of Gdansk

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).

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-09
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-10
• Last Update Posted: 2020-04-13
• Primary Completion: 2020-12
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
haemodynamics measuring	PICCO	those with already implemented PICCO device get impedance device (NICCOMO) attached
haemodynamics measuring	NICCOMO	those with already implemented PICCO device get impedance device (NICCOMO) attached

Primary Outcome Measures

Name	Time	Method
Numbers of measurements of haemodynamic parameters (CO, CI, SV, SVV, CI, SVR, SVRI) obtained with impedance, that differ from those obtained with thermodilution	up to 90 minutes	measurements taken with impedance and thermodilution simultaneously, at PEEP 0, 5, 10, 15, 20 and at optimal PEEP

Trial Locations

Locations (1)

Medical University of Gdansk; 🇵🇱 Gdansk, Poland