Evaluation of Goal-Directed Intraoperative Hemodynamic Optimization Protocol



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2013
End Date:December 2017
Contact:Maxime Cannesson, MD, PhD
Email:mcanness@uci.edu
Phone:(714) 456-8869; 6652

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As part of a quality assurance program, the Department of Anesthesiology implemented a
Goal-Directed Fluid Management training course for all physicians and nurses to provide
goal-directed fluid management. We intend to assess whether there has been any improvement
in patient outcomes by analyzing de-identified clinical information that are readily
available via the medical center electronic medical record system. The time-frame we are
interested in is one year before and one year after the Goal-Directed Fluid Management
training curriculum (June 15, 2011 to September 15, 2013).

A number of published studies in anesthesia have demonstrated that certain patient factors
may impact patient perioperative outcomes. Factors such as age, gender, cardiac function,
and hemodynamic status all have been shown to be predictive indicators. The goal of the
present study is to evaluate these factors with the effectiveness of the Goal Directed Fluid
Management training on patient outcomes after major surgeries and document the final
perioperative outcomes.

This is an observational study in which patients' de-identified clinical information will be
extracted from the University of California, Irvine Medical Center electronic medical record
system to evaluate whether there has been a change in patients' outcomes after the
Goal-Directed Fluid Management training curriculum was implemented. We will extract data
from both before and after the training took place-- the time-frame is from June 15, 2011 to
September 15, 2013. Specifically we will be looking at 30 day re-admission and 90 day
mortality following surgery. There are no study procedures or use of biological material.
Patient identifies are utilized in the secure database as this is utilized for clinical
management. When the data is extracted from the database for research purposes the patient
identifiers will be removed and no patient identifiers will be included in the information
during statistical analysis or subsequent reporting. For publication, only aggregate data is
utilized. No identifiable patient information will be released at any time.

Statistical considerations may include: Sample Size Considerations, Predictors,
Covariates/Cofounders, Statistical Goal(s), Statistical Approach, and Secondary Analysis.
Specifically, statistical analysis will be performed using computerized software (SPSS for
Windows version 12.0). For data that was non-normally distributed a Mann Mann-Whitney test
will be used and normally distributed data will be compared using the Student T-test.
Ordinal and nominal data will compared using Chi-Square analysis. A p value smaller or equal
to 0.05 will be considered significant. These statistical considerations will aid in
supporting the study's hypothesis for patient outcomes improvement with Early Goal Directed
Fluid Management training.

Inclusion Criteria:

- Patients aged 18 years or older,

- Patients undergoing one or more of the following high risk surgeries: liver
resection, pancreatectomy, cancer debulking, colorectal surgery,

- Surgical procedures must be projected to last longer than 2 hours,

- Patients receiving

Exclusion Criteria:

- Pregnant

- Under 18 years of age
We found this trial at
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Orange, California 92868
Phone: 714-456-8998
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