Viewing Study NCT04030221



Ignite Creation Date: 2024-05-06 @ 1:27 PM
Last Modification Date: 2024-10-26 @ 1:14 PM
Study NCT ID: NCT04030221
Status: UNKNOWN
Last Update Posted: 2019-07-23
First Post: 2019-07-19

Brief Title: Pressure Gradient for Venous Return in Predicting Fluid Responsiveness in Patients Undergoing Laparoscopic Surgery
Sponsor: Second Affiliated Hospital School of Medicine Zhejiang University
Organization: Second Affiliated Hospital School of Medicine Zhejiang University

Study Overview

Official Title: The Pressure Gradient for Venous Return PVR in Predicting Fluid Responsiveness in Patients Undergoing Laparoscopic Surgery
Status: UNKNOWN
Status Verified Date: 2019-07
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 PPVSVV in predicting fluid responsiveness FR In the case that PPVSVV 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 infusionThrough 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None