Mini-fluid Challenge as a Predictor of Fluid Response for Pneumoperitoneum Patient

January 28, 2020 updated by: Changhua Christian Hospital
The purpose of this study is to evaluate whether the change of stroke volume index(△SVI) induced by the rapid mini-fluid administration can predict fluid responsiveness in patients with pneumoperitoneum

Study Overview

Status

Withdrawn

Conditions

Detailed Description

Perioperative fluid management is significant important during surgery. The current trend tends to use goal-directed fluid therapy in surgery. Goal-directed fluid therapy refers to continuous monitoring of hemodynamic parameters during surgery and managing more accurate fluid administration based on the data obtained while promoting optimal tissue perfusion. Define fluid responsiveness with the hemodynamic parameters as to whether the cardiac output can be significantly increased after administration of fluid. Therefore, the advantage of predicting fluid responsiveness is that it can optimize the cardiac output and tissue perfusion while avoiding administering unnecessary fluid to patients.

The purpose of this study is to evaluate whether the change of stroke volume index(△SVI) induced by the rapid mini-fluid administration can predict fluid responsiveness in patients with pneumoperitoneum.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

receive operation that required pneumoperitoneum and FloTrac monitoring

Description

Inclusion Criteria:

  • receive operation that required pneumoperitoneum and FloTrac monitoring
  • ASA 1~3
  • age between 20 to 70 year old

Exclusion Criteria:

  • patient who cannot understand the process and aim of the study
  • patient with arrhythmia
  • poor heart function(LVEF<50%, severe valvular disease, CAD)
  • CKD
  • pregnant patient
  • patients allergic to voluven

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of stroke volume index
Time Frame: 1 hours
record stroke volume index before and after mini-fluid challenge
1 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

February 13, 2019

First Submitted That Met QC Criteria

February 14, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 181239

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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