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Clinical Trials/NCT04030221
NCT04030221
Unknown
Not Applicable

The Pressure Gradient for Venous Return (PVR) in Predicting Fluid Responsiveness in Patients Undergoing Laparoscopic Surgery

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country40 target enrollmentJuly 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fluid Responsiveness
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
40
Locations
1
Primary Endpoint
hemodynamic parameters
Last Updated
6 years ago

Overview

Brief Summary

Surgical patients, especially those with insufficient blood volume and hypotension, often need fluid therapy. However, there is still a lack of simple and reliable indicators for judging transfusion responsiveness in some types of surgery. Previous studies have shown that Pressure Gradient for Venous Return (PVR) can be used to guide infusion. Thus, our aim is to explore the relationship between PVR and liquid reactivity.

Detailed Description

Fluid resuscitation is one of the key issues in the management of surgery and anesthesia. Fluid infusion test is a method to determine patients' reactivity to liquid therapy. The commonly used Stroke Volume Variation (SVV) and Pulse Pressure Variation (PPV) are good predictors of fluid responsiveness, but they are not suitable for operations with increased intra-abdominal pressure, such as laparoscopy surgery. Some studies have shown that Pressure Gradient for Venous Return (PVR) may has the same effect as PPV/SVV in predicting fluid responsiveness (FR). In the case that PPV/SVV cannot be used, PVR may be used alternatively. Therefore, our aim is to explore the relationship between the changes of PVR and fluid responsiveness during liquid infusion and to determine relevant parameters. We will choose patients planed to receive laparoscopic surgery and general anesthesia, especially the patients with gastrointestinal tumors because of generally long operation time and much infusion volume. In our hospital, these patients will routinely indwelled arterial catheters and deep venous catheters during the operation. The former is mainly used to monitor direct arterial pressure, and the latter is used for fluid infusion.Through the above two pathways, we can collect the hemodynamic parameters of patients, and then establish the relationship between PVR and FR. In our study, a good FR was defined as a 10% increase in cardiac index (CI) after fluid infusion, and PVR is calculated by a special formula based on some specific parameters of hemodynamics.

Registry
clinicaltrials.gov
Start Date
July 20, 2019
End Date
August 20, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients undergoing laparoscopic surgery and general anesthesia

Exclusion Criteria

  • cardiac insufficiency; severe arrhythmias; patients using intra-aortic balloon pump; use of left ventricular assist devices; spasm of peripheral arteries caused by some factor

Outcomes

Primary Outcomes

hemodynamic parameters

Time Frame: At enrollment

direct arterial pressure including systolic, diastolic and mean arterial pressure; central venous pressure.These data are collected continuously and dynamically.

Study Sites (1)

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