Cardiovascular Diagnostic TechniquesNCT02572739
Cardiac Output Measurement With NICCOMO and PiCCO Devices at Different PEEP Levels
An observational study of Cardiovascular Diagnostic Techniques, run by Medical University of Gdansk at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diagnostic Techniques
- What is being tested?
- PICCO and NICCOMO
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- May 2014to Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated in intensive therapy unit, mechanically ventilated, haemodynamics monitored with PiCCO technique
Who may be able to join
- critically ill patients
- patients on mechanical ventilation
- circulatory insufficiency (present or in the past) monitored with with PiCCO device
Who cannot join
- morbid obesity,
- short neck,
- severe pneumonia,
- inability to NICCOMO electrodes attachment,
- massive tissue oedema,
- non-sinus cardiac rhythm,
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- tachycardia,
- low cardiac output,
- septic shock,
- heart valve pathologies,
- severe atherosclerosis,
- aortic prosthesis,
- severe hypertension,
- extremes of height and weight,
- intraaortic pump
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdansk
Gdansk, 80-214
Magdalena A Wujtewicz, +48583493357, magwuj@gumed.edu.pl
Radoslaw Owczuk, 605408140, r.owczuk@gumed.edu.pl
About this study
Official title: 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.
Read the 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).
- Conditions
- Cardiovascular Diagnostic Techniques
- Being tested
- PICCO, NICCOMO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICCODevice
measurements based on thermodilution
NICCOMODevice
measurements based on impedance
| Study group | Role | What they receive |
|---|---|---|
| haemodynamics measuring | those with already implemented PICCO device get impedance device (NICCOMO) attached Receives: Device: PICCO; Device: NICCOMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of measurements of haemodynamic parameters (CO, CI, SV, SVV, CI, SVR, SVRI) obtained with impedance, that differ from those obtained with thermodilution
measurements taken with impedance and thermodilution simultaneously, at PEEP 0, 5, 10, 15, 20 and at optimal PEEP
Measured: up to 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startMay 2014
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diagnostic TechniquesStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Wujtewicz, Medical University of Gdansk
- Investigators
- Magdalena Wujtewicz, Principal investigator, Department of Ophthalmology, Medical University of Gdańsk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572739
- Sponsor's protocol ID
- GUMed-Wu-002
- Status last verified
- Apr 2020
- First submitted
- 23 Sep 2015
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02572739
- Acronym / sponsor ID
- GUMed-Wu-002
- Conditions
- Cardiovascular Diagnostic Techniques
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| haemodynamics measuring | – | Device: PICCO, Device: NICCOMOthose with already implemented PICCO device get impedance device (NICCOMO) attached |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated in intensive therapy unit, mechanically ventilated, haemodynamics monitored with PiCCO technique
Key inclusion criteria (3 listed)
- critically ill patients
- patients on mechanical ventilation
- circulatory insufficiency (present or in the past) monitored with with PiCCO device
Key exclusion criteria (15 listed)
- morbid obesity,
- short neck,
- severe pneumonia,
- inability to NICCOMO electrodes attachment,
- massive tissue oedema,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICCOmeasurements based on thermodilution | Device | haemodynamics measuring |
| NICCOMOmeasurements based on impedance | Device | haemodynamics measuring |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena Wujtewicz principal investigator
Department of Ophthalmology, Medical University of Gdańsk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diagnostic Techniques, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magdalena A Wujtewicz (+48583493357, magwuj@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.