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 (COMPARE)

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Cardiac Output, Low
• Intervention / Treatment: Diagnostic test: >15% SV increase during fluid challenge

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Jean Yves LEFRANT; Email: jean.yves.lefrant@chu-nimes.fr

Study Locations

• France
  • Nimes 9, France, 30029
    • Recruiting
    • CHU de Nimes
    • Contact: Jean Yves LEFRANT, MD, PhD; Email: jean.yves.lefrant@chu-nimes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for intermediate and high-risk abdominal surgery were eligible to participate

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hemodynamic optimization; Patients scheduled for intermediate and high-risk abdominal surgery were eligible to participate	Diagnostic test: >15% SV increase during fluid challenge; The stroke volume will be measured before and after 15 minutes fluid challenge with crystalloids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of pulse contour for diagnosing a >15% increase in stroke volume	Ability of pulse contour for diagnosing a >15% increase in stroke volume	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	15 minutes

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: stroke volume; hemodynamic optimization; High risk abdominal surgery; pulse contour
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Output, Low
• Other Study ID Numbers: LOCAL/2021/PC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No