A Comparison of Thoracic Electrical Bioimpedance and FloTrac/Vigileo

Not Applicable

Not yet recruiting

• Conditions: Stroke Volume Variation; Thoracic Electrical Bioimpedance; Fluid Responsiveness; SVV-FloTrac
• Interventions: Device: Flotrac Group; Device: BioZ Group

• Registration Number: NCT06143111
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-19
• Last Update Submitted: 2023-11-19
• Study Start: 2023-11-20
• Study First Posted: 2023-11-22
• Last Update Posted: 2023-11-22
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flotrac Group	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.
BioZ Group	BioZ Group	In this group,haemodynamic parameters were collected simultaneously by the thoracic bioimpedance (BioZ.com™) monitoring.

Primary Outcome Measures

Name	Time	Method
The agreement between simultaneously measured SVV-FloTrac and SVV-BioZ	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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Pudong, Shanghai, China