A Comparison of Thoracic Electrical Bioimpedance and FloTrac/Vigileo

NCT ID: NCT06143111

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Stroke Volume Variation SVV-FloTrac Thoracic Electrical Bioimpedance Fluid Responsiveness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Flotrac Group

Intervention Type DEVICE

Haemodynamic parameters were collected simultaneously by the Flotrac monitoring.

BioZ Group

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

Group Type EXPERIMENTAL

BioZ Group

Intervention Type DEVICE

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

Interventions

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Flotrac Group

Haemodynamic parameters were collected simultaneously by the Flotrac monitoring.

Intervention Type DEVICE

BioZ Group

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Renji Hospital, Shanghai Jiaotong University School of Medicine

Pudong, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Diansan Su, Dr.

Role: CONTACT

+862168383702

Yuwen Cheng

Role: CONTACT

+862168383702

Other Identifiers

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LY2023-168-B

Identifier Type: -

Identifier Source: org_study_id