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Evaluation of Goal-Directed Intraoperative Hemodynamic Optimization Protocol

Evaluation of Goal-Directed Intraoperative Hemodynamic Optimization Protocol

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02057653
Enrollment
330
Registered
2014-02-07
Start date
2013-11-30
Completion date
2016-10-31
Last updated
2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

Goal-directed fluid management

Brief summary

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).

Detailed description

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.

Interventions

None listed

Sponsors

University of California, Irvine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The difference in length of stay in the hospital after surgery between pre-curriculum and post-curriculum cohorts.records will be assessed an expected average of 1 year before curriculum (June 2011) and 1 year after curriculum (September 2013) June 15, 2011- September 15, 2013Length of stay in the hospital (number of nights) after the surgery

Secondary

MeasureTime frameDescription
Incidence of postoperative pneumonia30 days after surgeryPneumonia defined according to the NSQIP database
Incidence of urinary tract infection30 days after surgeryUrinary tract infection defined according to the NSQIP database
Incidence of myocardial infarction30 days after surgeryMyocardial infarction defined according to the NSQIP database
Incidence of deep vein thrombosis30 days after surgeryDeep vein thrombosis defined according to the NSQIP database
Incidence of surgical site infection30 days after surgerySurgical site infection defined according to the NSQIP database
Incidence of sepsis30 days after surgerySepsis defined according to the NSQIP database
30 days readmission rate30 days after discharge from hospitalUnplanned readmission within 30 days after hospital discharge.
Incidence of intraoperative transfusionintraoperatively (Day 1, during surgery)Blood product transfusion during surgery
Incidence of post anesthesia care unit transfusion30 days after surgery in the PACUBlood product transfusion in the post anesthesia care unit (PACU)
Incidence of atrial fibrillation30 days after surgeryAtrial fibrillation defined according to the NSQIP database

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026