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Pulse CONtour and BIoimpedance for Measurements of Stroke Volume During Changes in CARdiac Preload

NCT04231656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-21

No results posted yet for this study

Summary

Fluid therapy guided by stroke volume response to repeated fluid challenges is used for hemodynamic optimization during general anesthesia. Two types of devices that measure stroke volume non-invasively are primarily available for intermediate-risk surgery under general anesthesia. They are based on two different techniques, (1) pulse contour analysis, and (2) transthoracic bioimpedance. They have never been compared with each other. Therefore, it is not known (1) whether they are interchangeable for the measurement of stroke volume changes (usually assessed as the "concordance" of two techniques), and (2) whether one is better than the other.

The aim is to study the concordance of these two non-invasive hemodynamic devices. it will use both of them in patients undergoing intermediate risk surgery. They will be tested during modifications of cardiac preload induced by Trendelenburg and anti-Trendelenburg positioning, as well as during intraoperative fluid challenges, vasopressor boluses and alveolar recruitment maneuvers.

Conditions

  • Hemodynamic, Monitoring
  • Anesthesia
  • Blood Pressure

Interventions

DEVICE

CLEARSIGHT and NICCOMO measurements in sequence A

Starting from 0° position, shift to position +20°, then tilt to -20°, and finally back to the 0° position.

DEVICE

CLEARSIGHT and NICCOMO measurements in sequence B

Starting from 0° position, shift to position -20°, then tilt to +20°, and finally back to the 0° position and collect the last group of figures.

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Benoit Tavernier, MD,PhD · University Hospital Lille, France

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2020-05-07
Completion
2020-05-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04231656 on ClinicalTrials.gov