SurgeryCOMPARENCT04871620
Reliability of a New Pulse Contour Technique for Diagnosing an Increase in Stroke Volume During a Fluid Challenge for Hemodynamic Optimization in Patients Scheduled for High-risk Abdominal Surgery: Comparison With Transthoracic Echocardiography: COMPARE Study
An observational study of Surgery and Cardiac Output, Low, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The present study aims at assessing the ability of a new pulse contour device for diagnosing a >15% stroke volume (SV) increase during patient hemodynamic optimization by fluid challenge in high risk abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Cardiac Output, Low
- What is being tested?
- >15% SV increase during fluid challenge
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2016to 8 Jan 2024
- 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 scheduled for intermediate and high-risk abdominal surgery were eligible to participate
Who may be able to join
- Adult patient ASA status 1-3 who were orally informed and did refuse to participate.
- Patient in whom general anesthesia with tracheal intubation were planned.
- Patient in whom an arterial catheter and a monitoring of cardiac output by esophageal Doppler were indicated for hemodynamic optimization
- Patient with cardiac sinusal mode
Who cannot join
- Patient < 18-year-old
- Cardiac arrythmia
- Patient with anomaly in oro-pharyngo-esophageal tractus
- Patients with hemostasis anomaly (PT < 30%, platelets < 50 000 elements/mm3)
- Patient in whom the cardiac output monitoring or measurement was not possible by Esophageal Doppler or echography
- Patients in whom cardiac arrythmia occurred during the procedure of hemodynamic optimization.
Trial locations and contacts
1 site in 1 country.
About this study
The present study aims at assessing the ability of a new pulse contour device for diagnosing a >15% stroke volume (SV) increase during patient hemodynamic optimization by fluid challenge in high risk abdominal surgery.
Read the detailed description
In European countries, day-7 mortality rate could reach 1-5. %. Emergency conditions, American Society Assessment (ASA) and major surgery were associated with a higher risk of immediate mortality. Moreover, hemodynamic instability is well known to lead to postoperative complications and a higher risk of mortality.
Since, nearly 30 years, optimization of hemodynamic conditions, especially via an optimization of the fluid administration has been shown to improve immediate and long-term patient outcome. This strategy is currently widely accepted and recommended in medium and high-risk surgery. Therefore, optimizing cardiac output and one of its surrogate is proposed over intraoperative surgery. For assessing the cardiac output or the indexed stroke volume, esophageal Doppler and pulse contour technique have been proposed and have shown that they could improve patient outcome.
However, the reliability of esophageal Doppler, pulse contour and non-invasive techniques assessing cardiac output and its ability to detect a change in the initial value of CO have been challenged. Initially, the reliability of a technique for measuring CO has been described by using a correlation coefficient and by building Bland \& Altman diagram. However, searching a correlation between two different techniques measuring the same parameter will lead to a correlation. In the same, Bland \& Altman technique shows the mean difference between measurements of the same parameters; However, demonstrating a good reliability should be shown by a narrow limit of agreement with no definition of the narrowness. Indeed, a value of cardiac index (CI) = 3 l/min/m2 with a mean difference of 0 +/- 1.1 /min/m2 by Bland \& Altman technique mean that the CI value could be within 1 and 5 l/min/m2 that could lead to different treatment such as fluid challenge, vasopressor or inotrope infusion.
An interesting method for comparing two techniques measuring the same parameter could be to challenge one technique versus the other one in decision-making. Applying this method to techniques measuring CO, we could search for the interest of a new technique for diagnosing an increase in CO after a fluid challenge for optimizing cardiac preload and hemodynamic status. Esophageal Doppler is classically recommended for optimizing hemodynamic patient in high-risk surgery.
A new device using pulse contour technology has been available since a few years. Therefore, the present study aims at assessing the ability of this device for diagnosing an increase in CO > 15% during patient hemodynamic optimization by fluid challenge.
- Conditions
- Surgery, Cardiac Output, Low
- Being tested
- >15% SV increase during fluid challenge
- Keywords
- High risk abdominal surgery, hemodynamic optimization, stroke volume, pulse contour
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
>15% SV increase during fluid challengeDiagnostic test
The stroke volume will be measured before and after 15 minutes fluid challenge with crystalloids
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamic optimization | Patients scheduled for intermediate and high-risk abdominal surgery were eligible to participate Receives: Diagnostic Test: >15% SV increase during fluid challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of pulse contour for diagnosing a >15% increase in stroke volume
Ability of pulse contour for diagnosing a >15% increase in stroke volume
Measured: 15 minutes
Secondary outcomes (2)
Comparison with the ability of other techniques
Comparison with the ability of other techniques (Esophagial Doppler, other pulse contour techniques for diagnosing a >15% SV increase)
Measured: 15 minutes
Ability for predicting a >15% SV increase
Ability of Esophagial Doppler and Pulse contour techniques for predicting a >15% SV increase after rapid infusion of 100ml cristalloid over one minute (mini-fluid challenge)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start12 Apr 2016
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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 (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871620
- Sponsor's protocol ID
- IRB 15.11.02
- Acronym
- COMPARE
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2021
- Last updated
- 18 Jun 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of a New Pulse Contour Technique for Diagnosing an Increase in Stroke Volume During a Fluid Challenge for Hemodynamic Optimization in Patients Scheduled for High-risk Abdominal Surgery: Comparison With Transthoracic Echocardiography: COMPARE Study
- ClinicalTrials.gov ID
- NCT04871620
- Acronym / sponsor ID
- COMPARE / IRB 15.11.02
- Conditions
- Surgery, Cardiac Output, Low
- Keywords
- High risk abdominal surgery, hemodynamic optimization, stroke volume, pulse contour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 4 May 2021 (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 present study aims at assessing the ability of a new pulse contour device for diagnosing a >15% stroke volume (SV) increase during patient hemodynamic optimization by fluid challenge in high risk abdominal surgery.
Detailed description
In European countries, day-7 mortality rate could reach 1-5. %. Emergency conditions, American Society Assessment (ASA) and major surgery were associated with a higher risk of immediate mortality. Moreover, hemodynamic instability is well known to lead to postoperative complications and a higher risk of mortality.
Since, nearly 30 years, optimization of hemodynamic conditions, especially via an optimization of the fluid administration has been shown to improve immediate and long-term patient outcome. This strategy is currently widely accepted and recommended in medium and high-risk surgery. Therefore, optimizing cardiac output and one of its surrogate is proposed over intraoperative surgery. For assessing the cardiac output or the indexed stroke volume, esophageal Doppler and pulse contour technique have been proposed and have shown that they could improve patient outcome.
However, the reliability of esophageal Doppler, pulse contour and non-invasive techniques assessing cardiac output and its ability to detect a change in the initial value of CO have been challenged. Initially, the reliability of a technique for measuring CO has been described by using a correlation coefficient and by building Bland \& Altman diagram. However, searching a correlation between two different techniques measuring the same parameter will lead to a correlation. In the same, Bland \& Altman technique shows the mean difference between measurements of the same parameters; However, demonstrating a good reliability should be shown by a narrow limit of agreement with no definition of the narrowness. Indeed, a value of cardiac index (CI) = 3 l/min/m2 with a mean difference of 0 +/- 1.1 /min/m2 by Bland \& Altman technique mean that the CI value could be within 1 and 5 l/min/m2 that could lead to different treatment such as fluid challenge, vasopressor or inotrope infusion.
An interesting method for comparing two techniques measuring the same parameter could be to challenge one technique versus the other one in decision-making. Applying this method to techniques measuring CO, we could search for the interest of a new technique for diagnosing an increase in CO after a fluid challenge for optimizing cardiac preload and hemodynamic status. Esophageal Doppler is classically recommended for optimizing hemodynamic patient in high-risk surgery.
A new device using pulse contour technology has been available since a few years. Therefore, the present study aims at assessing the ability of this device for diagnosing an increase in CO > 15% during patient hemodynamic optimization by fluid challenge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic optimization | – | Diagnostic Test: >15% SV increase during fluid challengePatients scheduled for intermediate and high-risk abdominal surgery were eligible to participate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for intermediate and high-risk abdominal surgery were eligible to participate
Key inclusion criteria (4 listed)
- Adult patient ASA status 1-3 who were orally informed and did refuse to participate.
- Patient in whom general anesthesia with tracheal intubation were planned.
- Patient in whom an arterial catheter and a monitoring of cardiac output by esophageal Doppler were indicated for hemodynamic optimization
- Patient with cardiac sinusal mode
Key exclusion criteria (6 listed)
- Patient < 18-year-old
- Cardiac arrythmia
- Patient with anomaly in oro-pharyngo-esophageal tractus
- Patients with hemostasis anomaly (PT < 30%, platelets < 50 000 elements/mm3)
- Patient in whom the cardiac output monitoring or measurement was not possible by Esophageal Doppler or echography
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 |
|---|---|---|
| >15% SV increase during fluid challengeThe stroke volume will be measured before and after 15 minutes fluid challenge with crystalloids | Diagnostic test | Hemodynamic optimization |
Primary outcome
Ability of pulse contour for diagnosing a >15% increase in stroke volume
Time frame: 15 minutes
Ability of pulse contour for diagnosing a >15% increase in stroke volume
2 secondary outcomes
Comparison with the ability of other techniques
Time frame: 15 minutes
Ability for predicting a >15% SV increase
Time frame: 15 minutes
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 Jun 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 Surgery and Cardiac Output, Low, run by Centre Hospitalier Universitaire de Nīmes 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 4 inclusion and 6 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 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?
Ability of pulse contour for diagnosing a >15% increase in stroke volume (time frame: 15 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 18 Jun 2026.