Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04871620
Acronym
COMPARE
Enrollment
100
Registered
2021-05-04
Start date
2016-04-12
Completion date
2024-01-08
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Output, Low, Surgery

Keywords

High risk abdominal surgery, hemodynamic optimization, stroke volume, pulse contour

Brief 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.

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.

Interventions

DIAGNOSTIC_TEST>15% SV increase during fluid challenge

The stroke volume will be measured before and after 15 minutes fluid challenge with crystalloids

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Ability of pulse contour for diagnosing a >15% increase in stroke volume15 minutesAbility of pulse contour for diagnosing a \>15% increase in stroke volume

Secondary

MeasureTime frameDescription
Comparison with the ability of other techniques15 minutesComparison with the ability of other techniques (Esophagial Doppler, other pulse contour techniques for diagnosing a \>15% SV increase)
Ability for predicting a >15% SV increase15 minutesAbility 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026