A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Stroke Volume Variation; Thoracic Electrical Bioimpedance; SVV-FloTrac; Fluid Responsiveness

Treatments: Device: Flotrac Group; Device: BioZ Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06215157

TEB-Zhoujie

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Flotrac Group

Active Comparator group

Description:

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.

Treatment:

Device: Flotrac Group

BioZ Group

Experimental group

Description:

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

Treatment:

Device: BioZ Group