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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)

16 juni 2026 uppdaterad av: Centre Hospitalier Universitaire de Nīmes
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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

100

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Nîmes, Frankrike, 30029
        • CHU de Nîmes

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Hemodynamic optimization
Patients scheduled for intermediate and high-risk abdominal surgery were eligible to participate
The stroke volume will be measured before and after 15 minutes fluid challenge with crystalloids

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Ability of pulse contour for diagnosing a >15% increase in stroke volume
Tidsram: 15 minutes
Ability of pulse contour for diagnosing a >15% increase in stroke volume
15 minutes

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Comparison with the ability of other techniques
Tidsram: 15 minutes
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
Tidsram: 15 minutes
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

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 april 2016

Primärt slutförande (Faktisk)

8 januari 2024

Avslutad studie (Faktisk)

8 januari 2024

Studieregistreringsdatum

Först inskickad

29 april 2021

Först inskickad som uppfyllde QC-kriterierna

29 april 2021

Första postat (Faktisk)

4 maj 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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