ShockCONDUCTNCT02728791
Comparison of Allows Measurement of Cardiac Output Between Clearsight System and Transpulmonary Thermodilution
An observational study of Shock and Cardiac Output, Low, run by University Hospital, Brest at 1 site in France.
Trial summary
Correlation study between the data provided by two measurement systems, trans- pulmonary thermodilution and ClearSight © (non invasive), to determine the interest in routine use (cardiac output, cardiac index, stroke volume and blood pressure). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shock, Cardiac Output, Low
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2016to 25 Jul 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients hospitalized in ICU with hemodynamic failure requiring vasoactive drugs
Who may be able to join
- age>18
- hospitalized in surgical ICU, with hemodynamic instability or vaso-active drugs
- No opposition formulated
Who cannot join
- Impossibility of establishment of one of the cardiac output measurement devices
- Pregnant woman
- Refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparaison de Mesure de débit Cardiaque Entre système Clearsight® et Thermodilution Transpulmonaire.
Correlation study between the data provided by two measurement systems, trans- pulmonary thermodilution and ClearSight © (non invasive), to determine the interest in routine use (cardiac output, cardiac index, stroke volume and blood pressure).
Read the detailed description
Since 2014, Edwards society has developed a completely non-invasive monitoring device for measurement of blood pressure and continuous cardiac output without inserting foreign intravascular bodies in the patient. Initially tested on healthy volunteers cardiac disease -free, the correlation with the other devices seems to be good. If this ClearSight © system show a relevant accuracy in measuring blood pressure and cardiac output with a specific ICU hospitalized population, it could justify its place in the therapeutic arsenal of monitoring in intensive care.
This is a common care ,prospective observational single center study , concerning the results of blood pressure , cardiac output values and their variations.
- Conditions
- Shock, Cardiac Output, Low
- Medical subject headings
- Shock, Cardiac Output, Low
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of values and changes in cardiac index between the two devices
Measured: 2 days
Secondary outcomes (3)
Comparison of values and variations in mean arterial pressure between the two devices
Measured: 2 days
Comparison of values and variations in mean cardiac output between the two devices
Measured: 2 days
Comparison of values and variations in mean stroke volume variation between the two devices
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start10 May 2016
- Primary completion25 Jul 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier HUET, Principal investigator, CHU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728791
- Sponsor's protocol ID
- 29BRC15.0144
- Acronym
- CONDUCT
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2016
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparaison de Mesure de débit Cardiaque Entre système Clearsight® et Thermodilution Transpulmonaire.
- ClinicalTrials.gov ID
- NCT02728791
- Acronym / sponsor ID
- CONDUCT / 29BRC15.0144
- Conditions
- Shock, Cardiac Output, Low
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 5 Apr 2016 (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.
Correlation study between the data provided by two measurement systems, trans- pulmonary thermodilution and ClearSight © (non invasive), to determine the interest in routine use (cardiac output, cardiac index, stroke volume and blood pressure).
Detailed description
Since 2014, Edwards society has developed a completely non-invasive monitoring device for measurement of blood pressure and continuous cardiac output without inserting foreign intravascular bodies in the patient. Initially tested on healthy volunteers cardiac disease -free, the correlation with the other devices seems to be good. If this ClearSight © system show a relevant accuracy in measuring blood pressure and cardiac output with a specific ICU hospitalized population, it could justify its place in the therapeutic arsenal of monitoring in intensive care.
This is a common care ,prospective observational single center study , concerning the results of blood pressure , cardiac output values and their variations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients hospitalized in ICU with hemodynamic failure requiring vasoactive drugs
Key inclusion criteria (3 listed)
- age>18
- hospitalized in surgical ICU, with hemodynamic instability or vaso-active drugs
- No opposition formulated
Key exclusion criteria (3 listed)
- Impossibility of establishment of one of the cardiac output measurement devices
- Pregnant woman
- Refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of values and changes in cardiac index between the two devices
Time frame: 2 days
3 secondary outcomes
Comparison of values and variations in mean arterial pressure between the two devices
Time frame: 2 days
Comparison of values and variations in mean cardiac output between the two devices
Time frame: 2 days
Comparison of values and variations in mean stroke volume variation between the two devices
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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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.
Olivier HUET principal investigator
CHU de Brest
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 and Cardiac Output, Low, run by University Hospital, Brest 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 25 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of values and changes in cardiac index between the two devices (time frame: 2 days). 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 25 Jun 2026.