Shock, CardiogenicNiccomo-CardNCT04643509
Validity of Cardiac Output Measurement Using Niccomo Device After Cardiac Surgery
An observational study of Shock, Cardiogenic and Surgery, run by University Hospital, Rouen at 1 site in France.
Trial summary
Cardiac surgery is at high risk of low cardiac output syndrome after procedure. Monitoring cardiac function, and especially cardiac output, is important to identify cardiovascular dysfunction and to introduce and adjust optimal therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Cardiogenic, Surgery, Output, Low Cardiac
- What is being tested?
- Niccomo
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2020to 23 Dec 2022
- 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: All patients bénéfiting from cardiac surgery and pulmonary arterial catheter at the discretion of the physician
Who may be able to join
- age > 18 y/o
- Patients benefiting from cardiac surgery AND pulmonary arterial catheter monitoring
Who cannot join
- Aortic regurgitation grade 3-4
- Uncontrolled Hypertension (MAP > 130 mmHg)
- Circulatory or cardiac assistance
- Active pacemaker
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Rouen University Hospital
Rouen, 76000
emmanuel besnier, MD, +33 2 32 88 82 83, emmanuel.besnier@chu-rouen.fr
About this study
Official title: Cardiac Output Analysis by Cardiographic Impedance: a Validation Study of the Niccomo Non-invasive Monitor in Post-operative Cardiac Surgery
Cardiac surgery is at high risk of low cardiac output syndrome after procedure. Monitoring cardiac function, and especially cardiac output, is important to identify cardiovascular dysfunction and to introduce and adjust optimal therapies. Invasive monitor such as pulmonary arterial catheter or transpulmonary thermodilution provide precise measurements but need an invasive access to arterial and central venous route, with possible complications.
Cardiographic bioimpedencemetry (Niccomo device, Imedex Corp) allows a non invasive measurement of cardiac output and some other parameters of cardiovascular function. Nevertheless, the reliability of this device has been little studied after cardiac surgery.
- Conditions
- Shock, Cardiogenic, Surgery, Output, Low Cardiac
- Being tested
- Niccomo
- Medical subject headings
- Shock, Cardiogenic, Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiccomoDevice
Niccomo monitoring added to pulmonary arterial catheter monitoring
| Study group | Role | What they receive |
|---|---|---|
| cardiac surgery | patients benefiting from pulmonary arterial catheter monitoring after cardiac surgery Receives: Device: Niccomo |
What is being measured
The primary outcome is the main question the study is designed to answer.
agreement between cardiac outputs measured by Pulmonary Arterial Catheter (PAC) and Niccomo
Cardiac outputs and systolic ejection volumes are measured at 10 different time-points and agreement between the 2 devices are explored
Measured: 48 hours
Secondary outcomes (4)
Systolic Time Ratio
Niccomo values at 10 different time-points
Measured: 48 hours
Pre-ejection Period
Niccomo values at 10 different time-points
Measured: 48 hours
Velocity Index
Niccomo values at 10 different time-points
Measured: 48 hours
Left Ventricular Ratio
Niccomo values at 10 different time-points
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start18 Dec 2020
- Primary completion18 Dec 2022 (estimated)
- Study completion23 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock, CardiogenicStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643509
- Sponsor's protocol ID
- 2019/020/OB
- Acronym
- Niccomo-Card
- Status last verified
- Nov 2020
- First submitted
- 19 Nov 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output Analysis by Cardiographic Impedance: a Validation Study of the Niccomo Non-invasive Monitor in Post-operative Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04643509
- Acronym / sponsor ID
- Niccomo-Card / 2019/020/OB
- Conditions
- Shock, Cardiogenic, Surgery, Output, Low Cardiac
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 18 Dec 2022 (estimated)
- Study completion
- 23 Dec 2022 (estimated)
- First posted
- 25 Nov 2020 (actual)
- 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.
Cardiac surgery is at high risk of low cardiac output syndrome after procedure. Monitoring cardiac function, and especially cardiac output, is important to identify cardiovascular dysfunction and to introduce and adjust optimal therapies. Invasive monitor such as pulmonary arterial catheter or transpulmonary thermodilution provide precise measurements but need an invasive access to arterial and central venous route, with possible complications.
Cardiographic bioimpedencemetry (Niccomo device, Imedex Corp) allows a non invasive measurement of cardiac output and some other parameters of cardiovascular function. Nevertheless, the reliability of this device has been little studied after cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac surgery | – | Device: Niccomopatients benefiting from pulmonary arterial catheter monitoring after cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients bénéfiting from cardiac surgery and pulmonary arterial catheter at the discretion of the physician
Key inclusion criteria (2 listed)
- age > 18 y/o
- Patients benefiting from cardiac surgery AND pulmonary arterial catheter monitoring
Key exclusion criteria (4 listed)
- Aortic regurgitation grade 3-4
- Uncontrolled Hypertension (MAP > 130 mmHg)
- Circulatory or cardiac assistance
- Active pacemaker
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 |
|---|---|---|
| NiccomoNiccomo monitoring added to pulmonary arterial catheter monitoring | Device | cardiac surgery |
Primary outcome
agreement between cardiac outputs measured by Pulmonary Arterial Catheter (PAC) and Niccomo
Time frame: 48 hours
Cardiac outputs and systolic ejection volumes are measured at 10 different time-points and agreement between the 2 devices are explored
4 secondary outcomes
Systolic Time Ratio
Time frame: 48 hours
Pre-ejection Period
Time frame: 48 hours
Velocity Index
Time frame: 48 hours
Left Ventricular Ratio
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 Shock, Cardiogenic and Surgery, run by University Hospital, Rouen at 1 site in France.
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 2 inclusion and 4 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 24 Dec 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 France. 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 Emmanuel Besnier, MD PhD (+33232881705, emmanuel.besnier@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
agreement between cardiac outputs measured by Pulmonary Arterial Catheter (PAC) and Niccomo (time frame: 48 hours). 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 24 Dec 2020.