Prospective Data Analysis of a Quality Improvement Initiative in High Risk Cardiac Surgery Patients

Prospective Data Analysis of a Quality Improvement Initiative for Perioperative Hemodynamic Optimization Therapy and Postoperative Outcomes in Patients Undergoing High-Risk Cardiac Surgery

This project is designed to assess the impact of implementing a hemodynamic optimization protocol, utilizing flow guided parameters that is provided by technology from Edwards Lifesciences, for patients undergoing high risk cardiac surgery. Importantly, this project is being targeted as a QI initiative because there is no evaluation of new technology or procedures. All technologies and procedures are currently being used for patients undergoing cardiac surgery. Rather this project is evaluating the implementation of a multi-dispclinary developed protocol that seeks to remove variability in which providers are currently treating patients hemodynamics during and acutely after cardiac surgery. Previous research has demonstrated that implementation of hemodynamic management protocols improves perioperative outcome in surgical patients. This project seeks to evaluate the impact of implementing this protocol as the new clinical standard for high-risk cardiac surgery patients. Specifically, this protocol would be a comprehensive hemodynamic management strategy that would-be initiated in the operating room post-bypass and then continued for the first 12 hours in the intensive care unit (see figure below). To restate, all technologies and procedures are currently being performed for these patients, however, there has not been a protocol guiding how practionioners use this technology. The project is evaluating the impact of protocolized treatment strategies. Importantly this protocol has been designed, reviewed and agreed by the motivation of the physicians who are currently responsible for managing these patients hemodynamics. Since this project does involve alterations in procedures or technologies we are seeking to proceed as a quality improvement project. Additionally the protocol is one that has been reviewed and agreed to provide the optimal management strategy for these patients. This again is the overall focus of this project, to implement a hemodynamic management protocol to improve outcomes in patients undergoing cardiac surgery.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Bypass Graft
• Intervention / Treatment: Device: Hemodynamic monitoring

• Study Type: Observational
• Enrollment (Actual): 195

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult high risk cardiac surgical patients undergoing procedures requiring cardiopulmonary bypass. High risk was defined, a priori, as patients who are expected to require an inotropic and/or vasoconstrictive agent for more than 12 hours post-CPB.

Description

Inclusion Criteria:

(1) the procedure was a first-start case, (2) the procedure was scheduled, (3) the procedure is considered non-emergent, and (4) the cardiac surgery required cardiopulmonary bypass

Exclusion Criteria:

(1) Patients less than 18 years of age, (2) failure to undergo CPB, (3) non-first-start or emergent classification, (4) as well those who did not receive at least 12 hours of inotropic and/or vasoconstrictive agents were excluded from the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	ICU length of stay	days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major postoperative complications identified as:	1) incidence of stroke, (2) incidence of renal failure (defined as a threefold or greater rise in creatinine or new dialysis requirement), (3) prolonged intubation (>24 hours), and/or (4) a sternal wound infection.	during hospitalization
Hospital length of stay		days
30-day readmission		days

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 5170287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No