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A Comparison of Thoracic Electrical Bioimpedance and FloTrac/Vigileo

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06143111
Enrollment
100
Registered
2023-11-22
Start date
2023-11-20
Completion date
2025-12-31
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Responsiveness, Stroke Volume Variation, SVV-FloTrac, Thoracic Electrical Bioimpedance

Brief summary

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.

Interventions

Haemodynamic parameters were collected simultaneously by the Flotrac monitoring.

Haemodynamic parameters were collected simultaneously by the thoracic bioimpedance (BioZ.com™)monitoring.

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The agreement between simultaneously measured SVV-FloTrac and SVV-BioZFrom 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.

Secondary

MeasureTime frameDescription
The capacity to predict fluid responsiveness.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.

Countries

China

Contacts

Primary ContactDiansan Su, Dr.
diansansu@yahoo.com+862168383702
Backup ContactYuwen Cheng
15373748@qq.com+862168383702

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026