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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06143111
Other study ID # LY2023-168-B
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 20, 2023
Est. completion date December 31, 2025

Study information

Verified date November 2023
Source RenJi Hospital
Contact Diansan Su, Dr.
Phone +862168383702
Email diansansu@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.comâ„¢) 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Flotrac Group
Haemodynamic parameters were collected simultaneously by the Flotrac monitoring.
BioZ Group
Haemodynamic parameters were collected simultaneously by the thoracic bioimpedance (BioZ.comâ„¢)monitoring.

Locations

Country Name City State
China Renji Hospital, Shanghai Jiaotong University School of Medicine Pudong Shanghai

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The capacity to predict fluid responsiveness. 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. From anesthesia induction to the nonresponsive VLS about one hour.
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