NCT04231656

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

Stoke Volume Measurements During Changes in Cardiac Preload: Are Pulse Contour Analysis (CLEARSIGHT) and Transthoracic Bioelectrical Impedance (NICCOMO) Equivalent?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The main objective is to assess the concordance of two non-invasive devices using the technology described above : the Clearsight (Edwards Lifesciences, pulse contour analysis), and the Niccomo (Medis, bioimpedance). Both will be used in each patient included in the study. They will be tested during modifications of cardiac preload induced by sequences of position changes (see below) including Trendelenburg and anti-Trendelenburg positioning, performed systematically before and after the procedure, as well as during fluid challenges, vasopressor boluses and alveolar recruitment maneuvers (performed during the procedure according to the needs of the anesthesiologist in charge of the patient). Both monitors will also be compared with an invasive monitor of stroke volume (Vigileo/Flotrac, Edwards Lifesciences), and the respiratory pulse pressure variation will also be measured during the sequences of position changes and will be used as a gold standard for fluid responsiveness.

Conditions

• Hemodynamic, Monitoring
• Anesthesia
• Blood Pressure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-12
• Primary completion: 2020-05-07
• Completion: 2020-05-07
• First posted: 2020-01-18
• Last updated: 2021-04-21

Locations

1 site across 1 country: France