Evaluation of Goal-Directed Intraoperative Hemodynamic Optimization Protocol
|ClinicalTrials.gov Identifier: NCT02057653|
Recruitment Status : Unknown
Verified February 2016 by Maxime Cannesson, University of California, Irvine.
Recruitment status was: Recruiting
First Posted : February 7, 2014
Last Update Posted : February 10, 2016
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Evaluation of Goal-Directed Intraoperative Hemodynamic Optimization Protocol|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
Before GDFM Training
Approximate 300 patients' medical record information will be extracted from the UC Irvine Medical Center electronic medical record prior to the start of the training curriculum.
After GDFM Training
Approximate 300 patients' medical record information will be extracted from the UC Irvine Medical Center electronic medical record after the training program took place
- The difference in length of stay in the hospital after surgery between pre-curriculum and post-curriculum cohorts. [ Time Frame: 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, 2013 ]Length of stay in the hospital (number of nights) after the surgery
- Incidence of surgical site infection [ Time Frame: 30 days after surgery ]Surgical site infection defined according to the NSQIP database
- Incidence of postoperative pneumonia [ Time Frame: 30 days after surgery ]Pneumonia defined according to the NSQIP database
- Incidence of urinary tract infection [ Time Frame: 30 days after surgery ]Urinary tract infection defined according to the NSQIP database
- Incidence of myocardial infarction [ Time Frame: 30 days after surgery ]Myocardial infarction defined according to the NSQIP database
- Incidence of deep vein thrombosis [ Time Frame: 30 days after surgery ]Deep vein thrombosis defined according to the NSQIP database
- Incidence of atrial fibrillation [ Time Frame: 30 days after surgery ]Atrial fibrillation defined according to the NSQIP database
- Incidence of sepsis [ Time Frame: 30 days after surgery ]Sepsis defined according to the NSQIP database
- 30 days readmission rate [ Time Frame: 30 days after discharge from hospital ]Unplanned readmission within 30 days after hospital discharge.
- Incidence of intraoperative transfusion [ Time Frame: intraoperatively (Day 1, during surgery) ]Blood product transfusion during surgery
- Incidence of post anesthesia care unit transfusion [ Time Frame: 30 days after surgery in the PACU ]Blood product transfusion in the post anesthesia care unit (PACU)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057653
|Contact: Maxime Cannesson, MD, PhD||(714) 456-8869; email@example.com|
|Contact: Davinder Ramsingh, MDfirstname.lastname@example.org|
|United States, California|
|UC Irvine Medical Center||Recruiting|
|Orange, California, United States, 92868|
|Contact: Cecilia Canales, MPH 714-456-8998 email@example.com|
|Sub-Investigator: Joseph Rinehart, MD|
|Sub-Investigator: Cameron Ricks, MD|
|Sub-Investigator: Shermeen Vakharia, MD|
|Sub-Investigator: Trung Vu, MD|
|Sub-Investigator: Cecilia Canales, MPH|
|Sub-Investigator: Davinder Ramsingh, MD|
|Principal Investigator:||Maxime Cannesson, MD, PhD||UC Irvine Medical Center, Dept. of Anesthesiology & Perioperative Care|