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

NCT ID: NCT02572739

Last Updated: 2020-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2021-03-31

Brief Summary

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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

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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).

Conditions

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Cardiovascular Diagnostic Techniques

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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haemodynamics measuring

those with already implemented PICCO device get impedance device (NICCOMO) attached

PICCO

Intervention Type DEVICE

measurements based on thermodilution

NICCOMO

Intervention Type DEVICE

measurements based on impedance

Interventions

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PICCO

measurements based on thermodilution

Intervention Type DEVICE

NICCOMO

measurements based on impedance

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Magdalena Wujtewicz

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magdalena Wujtewicz

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Medical University of Gdańsk

Locations

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Medical University of Gdansk

Gdansk, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Magdalena A Wujtewicz

Role: CONTACT

+48583493357

Radoslaw Owczuk

Role: CONTACT

605408140

Facility Contacts

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Magdalena A Wujtewicz

Role: primary

+48583493357

Radoslaw Owczuk

Role: backup

605408140

Other Identifiers

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GUMed-Wu-002

Identifier Type: -

Identifier Source: org_study_id

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