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

NCT04871620 | Unknown

• 1 other identifier: LOCAL/2021/PC-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Cardiac Output, Low

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison with the ability of other techniques

  15 minutes

• Ability for predicting a >15% SV increase

  15 minutes

Study Arms (1)

Hemodynamic optimization

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

Diagnostic Test: >15% SV increase during fluid challenge

Interventions

>15% SV increase during fluid challenge DIAGNOSTIC_TEST

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

Hemodynamic optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de NIMES

Nîmes, 30029, France

RECRUITING

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jean Yves LEFRANT

CONTACT

jean.yves.lefrant@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: January 1, 2016
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)