A Comparison of Thoracic Electrical Bioimpedance and FloTrac/Vigileo

NCT06143111 | Unknown

• 1 other identifier: LY2023-168-B
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The capacity to predict fluid responsiveness.

  From anesthesia induction to the nonresponsive VLS about one hour.

Study Arms (2)

Flotrac Group

ACTIVE COMPARATOR

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.

Device: Flotrac Group

BioZ Group

EXPERIMENTAL

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

Device: BioZ Group

Interventions

Flotrac Group DEVICE

Haemodynamic parameters were collected simultaneously by the Flotrac monitoring.

Flotrac Group

BioZ Group DEVICE

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

BioZ Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18≤ Age ≤65.
• patients undergoinglaparoscopic elective surgery for gastrointestinal tumors under general anesthesia
• kg/m2≤BMI≤30 kg/m2
• ASA classification I-III
• Patients signed informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine

Pudong, Shanghai Municipality, 200127, China

Location

Central Study Contacts

Diansan Su, Dr.

CONTACT

+862168383702; diansansu@yahoo.com

Yuwen Cheng

CONTACT

+862168383702; 15373748@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 22, 2023
• Study Start: November 20, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

CN (1)