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

NCT04458701 | Completed FDA Device

• 1 other identifier: 5170287
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Bypass Graft

Outcome Measures

Primary Outcomes (1)

• Length of Stay

  ICU length of stay

  days

Secondary Outcomes (3)

• Major postoperative complications identified as:

  during hospitalization

• Hospital length of stay

  days

• 30-day readmission

  days

Interventions

Hemodynamic monitoring DEVICE

This is 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Loma Linda University: lead
• Edwards Lifesciences: collaborator

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Interventions

Hemodynamic Monitoring

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Study Officials

• Davinder Ramsingh, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: January 17, 2019
• Primary Completion: February 1, 2020
• Study Completion: June 30, 2020
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)