A Comparison of Thoracic Electrical Bioimpedance and FloTrac/Vigileo

Fluid Responsiveness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06143111
• Other study ID #: LY2023-168-B
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: RenJi Hospital
• Contact: Diansan Su, Dr.
• Phone: +862168383702
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fluid Responsiveness
• Stroke
• Stroke Volume Variation

Intervention

Device:
• Flotrac Group
Haemodynamic parameters were collected simultaneously by the Flotrac monitoring.
• BioZ Group
Haemodynamic parameters were collected simultaneously by the thoracic bioimpedance (BioZ.com™)monitoring.

Locations

Country	Name	City	State
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Pudong	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The agreement between simultaneously measured SVV-FloTrac and SVV-BioZ	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	The capacity to predict fluid responsiveness.	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.