A Comparison of Thoracic Electrical Bioimpedance and FloTrac/Vigileo

November 19, 2023 updated by: RenJi Hospital

A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness Measured by Thoracic Electrical Bioimpedance and FloTrac/Vigileo

Stroke volume variation (SVV) is an indicator used to assess the patient's volume status. The FloTrac system (Edwards Lifesciences, Irvine, CA) continuously monitors cardiac output (CO) and SVV (SVV-FloTrac) by analyzing the systemic arterial pressure wave. Numerous studies have demonstrated that SVV-FloTrac serves as a reliable indicator of fluid responsiveness. However, its peripheral invasiveness raises concerns about susceptibility to reflecting waves, damping, and vascular tone influences.In contrast, Transthoracic electrical bioimpedance (BioZ.com™) offers a non-invasive approach for continuously monitoring various hemodynamic variables. In this study, the primary aim was to assess the agreement between simultaneously measured SVV-FloTrac and SVV-BioZ.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Pudong, Shanghai, China, 200127
        • Renji Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18≤ Age ≤65.
  • patients undergoinglaparoscopic elective surgery for gastrointestinal tumors under general anesthesia
  • 18 kg/m2≤BMI≤30 kg/m2
  • ASA classification I-III
  • Patients signed informed consent form

Exclusion Criteria:

  • Arrhythmias
  • The patient is diagnosed with severe cardiovascular disease（pulmonary arterial hypertension、left ventricular ejection fraction< 50%、aortic aneurysm、extensive peripheral arterial occlusive disease,、significant valvulopathy）
  • Severe heart failure (METS<4)
  • The patient is diagnosed with severe hepatic dysfunction (ChildePugh class C)
  • The patient is diagnosed with severe renal dysfunction (undergoing dialysis before surgery)
  • There is an infectious lesion on the skin or subcutaneous tissue where the non-invasive electrode piece is placed
  • History of allergy to anesthetic drugs
  • Weight<40kg
  • Allergies to 6% hydroxyethyl starch, Fresenius Kabi, Deutschland

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Flotrac Group
In this group,an arterial catheter was inserted preoperatively. An indwelling radial artery catheter was connected to the hemodynamic monitoring system (EV1000; Edward Lifesciences Corp., Irvine, CA, USA) via FloTrac™ (Edwards Lifesciences Corp.) sensors.
Device: Flotrac Group
Haemodynamic parameters were collected simultaneously by the Flotrac monitoring.
Experimental: BioZ Group
In this group,haemodynamic parameters were collected simultaneously by the thoracic bioimpedance (BioZ.com™) monitoring.
Device: BioZ Group
Haemodynamic parameters were collected simultaneously by the thoracic bioimpedance (BioZ.com™)monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The agreement between simultaneously measured SVV-FloTrac and SVV-BioZ
Time Frame: From anesthesia induction to the nonresponsive VLS about one hour.
After anesthesia induction, volume loading was initiated. For each volume loading step (VLS), 100 mL of colloid solution (6% hydroxyethyl starch) was administered over a 2-minute duration. The SVV was measured and recorded simultaneously by FloTrac (SVV-FloTrac) and Transthoracic electrical bioimpedance(SVV-BioZ). Volume loading steps (VLS) continued until no responsive VLS was observed. Responsive VLS, defined as an increase in Flotrac-SV by at least 5%, and nonresponsive VLS, characterized by no change or an increase in Flotrac-SV by less than 5%, were subsequently identified. Multiple analysis methods were used to determine the agreement of the two SVVs.
From anesthesia induction to the nonresponsive VLS about one hour.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The capacity to predict fluid responsiveness.
Time Frame: From anesthesia induction to the nonresponsive VLS about one hour.
After anesthesia induction, volume loading was initiated. For each volume loading step (VLS), 100 mL of colloid solution (6% hydroxyethyl starch) was administered over a 2-minute duration. The SVV was measured and recorded simultaneously by FloTrac (SVV-FloTrac) and Transthoracic electrical bioimpedance(SVV-BioZ). Volume loading steps (VLS) continued until no responsive VLS was observed. Responsive VLS, defined as an increase in Flotrac-SV by at least 5%, and nonresponsive VLS, characterized by no change or an increase in Flotrac-SV by less than 5%, were subsequently identified. Multiple analysis methods were used to determine the capacity to predict the fluid responsiveness of these two devices.
From anesthesia induction to the nonresponsive VLS about one hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 20, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 19, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 19, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2023-168-B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fluid Responsiveness

Clinical Trials on Flotrac Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe