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Clinical Trials/NCT06215157
NCT06215157
Not yet recruiting
Not Applicable

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

RenJi Hospital1 site in 1 country120 target enrollmentJanuary 30, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke Volume Variation
Sponsor
RenJi Hospital
Enrollment
120
Locations
1
Primary Endpoint
The capacity to predict fluid responsiveness.
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 30, 2024
End Date
December 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • The agreement between simultaneously measured SVV-FloTrac and SVV-BioZ(From anesthesia induction to the nonresponsive VLS about one hour.)

Study Sites (1)

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