Coronary SurgeryUPC-OPCSNCT06822361
Uncalibrated Pulse Contour to Assess Fluid Responsiveness in Off Pump Cardiac Surgery
An observational study of Coronary Surgery, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial summary
The goal of this observational study is to Compare the performance of uncalibrated pulse wave contour analysis compared with transesophageal echocardiography (TEE) to assess response to a vascular filling test during beating-heart coronary artery bypass surgery, in people over age of 18; hospitalized for scheduled… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Surgery
- How many people
- 55 participants
- Where
- 1 siteReunion
- Study dates
- 23 Dec 2024to 10 Oct 2025
- 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: Patient admitted to the cardiac surgery department for surgery under extracorporeal circulation
Who may be able to join
- Patient :
- 18 years of age and older
- Hospitalized for scheduled beating-heart coronary bypass surgery
- Beneficiary of a social security plan
- Not opposed to participating
Who cannot join
- Patients undergoing surgery with extracorporeal circulation
- Patients with a history of surgery or intra-esophageal pathology contraindicating TEE
- Patient refusing to participate in the study
- Unavailability of TEE or uncalibrated pulse-wave contour device
- Minors
- Protected adults, adults unable to give consent and not under protective supervision
Show all 10Show fewer
- Persons deprived of liberty, hospitalized without consent
- Pregnant women, parturients and nursing mothers
- Patients not affiliated to the social security system
- Emergency situations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Response to Vascular Filling by Uncalibrated Pulse Wave Contour Analysis in Beating Heart Cardiac Surgery
The goal of this observational study is to Compare the performance of uncalibrated pulse wave contour analysis compared with transesophageal echocardiography (TEE) to assess response to a vascular filling test during beating-heart coronary artery bypass surgery, in people over age of 18; hospitalized for scheduled beating heart bypass surgery The aim question is to evaluate the ability of a less invasive cardiac output monitor (uncalibrated pulse wave contour analysis) compared with a reference cardiac output measurement (transesophageal echocardiography) to enable optimization of vascular filling by good assessment of the response to vascular filling in a high-risk perioperative patient population.
As part of hemodynamic monitoring, every patient undergoing beating-heart coronary bypass surgery is fitted with a radial arterial catheter immediately after induction of anesthesia, enabling continuous measurement of blood pressure. Hemodynamic optimization in these patients also involves fitting a transesophageal ultrasound probe to optimize cardiac output using the various therapies available (vascular filling, vasopressors, inotropes).
Read more
A specific sensor (FloTrac°, Hemosphere, Edwards°) will be connected to the arterial pressure line to obtain a systolic ejection volume value by analyzing the contour of the uncalibrated pulse wave.
The hemodynamic management of the patient, and the decision to perform a vascular filling test, will be left to the discretion of the practitioner in charge of the patient in the operating room.
- Conditions
- Coronary Surgery
- Keywords
- vascular filling, systolic ejection volume, uncalibrated pulse-wave contour analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to vascular filling
an increase of more than 10% (compared with basal value) in the sub-aortic VTI value measured in TEE after filling (gold standard).
Measured: From enrollment to completion of chirurgy (24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start23 Dec 2024
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary SurgeryStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822361
- Sponsor's protocol ID
- 2024/CHU/57
- Other IDs
- 2024-A02390-47
- Acronym
- UPC-OPCS
- Status last verified
- Mar 2026
- First submitted
- 18 Dec 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Response to Vascular Filling by Uncalibrated Pulse Wave Contour Analysis in Beating Heart Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06822361
- Acronym / sponsor ID
- UPC-OPCS / 2024/CHU/57
- Conditions
- Coronary Surgery
- Keywords
- vascular filling, systolic ejection volume, uncalibrated pulse-wave contour analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 12 Feb 2025 (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.
The goal of this observational study is to Compare the performance of uncalibrated pulse wave contour analysis compared with transesophageal echocardiography (TEE) to assess response to a vascular filling test during beating-heart coronary artery bypass surgery, in people over age of 18; hospitalized for scheduled beating heart bypass surgery The aim question is to evaluate the ability of a less invasive cardiac output monitor (uncalibrated pulse wave contour analysis) compared with a reference cardiac output measurement (transesophageal echocardiography) to enable optimization of vascular filling by good assessment of the response to vascular filling in a high-risk perioperative patient population.
As part of hemodynamic monitoring, every patient undergoing beating-heart coronary bypass surgery is fitted with a radial arterial catheter immediately after induction of anesthesia, enabling continuous measurement of blood pressure. Hemodynamic optimization in these patients also involves fitting a transesophageal ultrasound probe to optimize cardiac output using the various therapies available (vascular filling, vasopressors, inotropes).
A specific sensor (FloTrac°, Hemosphere, Edwards°) will be connected to the arterial pressure line to obtain a systolic ejection volume value by analyzing the contour of the uncalibrated pulse wave.
The hemodynamic management of the patient, and the decision to perform a vascular filling test, will be left to the discretion of the practitioner in charge of the patient in the operating room.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to the cardiac surgery department for surgery under extracorporeal circulation
Key inclusion criteria (5 listed)
- 18 years of age and older
- Hospitalized for scheduled beating-heart coronary bypass surgery
- Beneficiary of a social security plan
- Not opposed to participating
Key exclusion criteria (10 listed)
- Patients undergoing surgery with extracorporeal circulation
- Patients with a history of surgery or intra-esophageal pathology contraindicating TEE
- Patient refusing to participate in the study
- Unavailability of TEE or uncalibrated pulse-wave contour device
- Minors
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
Response to vascular filling
Time frame: From enrollment to completion of chirurgy (24 hours)
an increase of more than 10% (compared with basal value) in the sub-aortic VTI value measured in TEE after filling (gold standard).
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 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Surgery, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 5 inclusion and 10 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 18 Mar 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 Reunion. 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?
Response to vascular filling (time frame: From enrollment to completion of chirurgy (24 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 18 Mar 2026.