Evaluation of Clinical Impact of Non-Invasive Hemodynamic Monitoring to Optimize Perioperative Care

Evaluation of Clinical Impact of Non-Invasive Hemodynamic Monitoring to Optimize Perioperative Care in Moderate to High Risk Patients With Poor Functional Status

This project is designed to assess the impact of pre-operative use of non-invasive hemodynamic monitoring technologies on improving peri-operative and post-operative care of moderate to high-risk surgical patients with poor functional status by improving the detection of reduced cardiovascular function.

Study Overview

• Status: Terminated
• Conditions: Hemodynamic Monitoring
• Intervention / Treatment: Device: invasive Hemodynamic monitoring via Clearsight/Nexfin Systems from Edwards Lifesciences; Device: No Hemodynamic Monitored Guided Assesment

Detailed Description

This study seeks to evaluate the impact of using a non-invasive technology to assess flow guided parameters (SV,SVR, dp/dt, CO, etc.) on patient care decisions in the preoperative settings. Patients seen in the preoperative clinic who are undergoing a moderate or high-risk procedure and have less than 4 metabolic equivalents (METs) will be approached to participate in the study .

Once consented, the device will be placed during the preoperative clinic visit and the data will be presented to the care team. Surveys will be completed by the health care provider for each consented patient to determine if the data from the device positively impacted patient care decisions. Specifically, the survey will evaluate if providing information on the patient's cardiovascular function (via the device used for this study) facilitated the health care provider to identify if the patient had reduced cardiovascular function. For the primary outcome, this study will evaluate if this device can assistant the identification of patients with reduced cardiovascular function by providing the flow guided parameter listed above. Secondary markers include the evaluation of perioperative complication rate (composite outcome ) between those that had the non-invasive HD data displayed to the preoperative team vs. not. Additional secondary makers will include: frequency of intraoperative hemodynamic optimization and goal directed fluid therapy administration, health care provider survey results, patient survey on the level of discomfort from wearing the cuff during the study. length of hospital stay, length of intensive care stay, readmission to the hospital within 30 days after hospital discharge, and 30-day postoperative mortality.

Outcome data will be collected using the electronic medical records database available at the investigators institution.

It is the hope of the investigators that this study will demonstrate that by simply applying the preoperative use of the non-invasive hemodynamic technologies one can:

1. more appropriately identify which patients would benefit from intraoperative hemodynamic monitoring strategies
2. increase satisfaction of the preoperative assessment by the health care provider
3. further validate the importance of caring for patients with knowledge of their volume status, contractility, and vascular resistance in other patient care settings.

• Study Type: Observational
• Enrollment (Actual): 189

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda Health
    • Loma Linda, California, United States, 92354
      • Loma Linda University Department of Anesthesiology
    • Loma Linda, California, United States, 92354
      • Pat Moore

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: Probability Sample

Study Population

Adult subjects with ASA classification level 3 and 4, with less than 5 metabolic events

Description

Inclusion Criteria:

1. Adult patients (greater than 18 years of age)
2. ASA classification 3 and 4 level patients with poor functional status,
3. less than 5 metabolic equivalents (METs) -

Exclusion Criteria:

1. < 18 years of age, pregnancy,
2. known severe peripheral artery disease,
3. poor perfusion to fingers (as defined as a perfusion index less than 0.5%- www.Masimo.com),
4. history of Raynaud's,
5. refusal to provide written consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hemodynamic Monitored Guided Assesment; This group will have the non-invasive hemodynamic monitoring device placed and the data will be used for comparison with routine subjective preoperative assessment assessment.	Device: invasive Hemodynamic monitoring via Clearsight/Nexfin Systems from Edwards Lifesciences; Experimental: Hemodynamic Monitored Guided Assesment This group will have the non-invasive hemodynamic monitoring device placed and its data will help guide (intervention) patient's management decisions (experimental).
No Hemodynamic Monitored Guided Assesment; This group will have subjective assessment by the provider and this data will be compared to the device assessment of cardiac index..	Device: No Hemodynamic Monitored Guided Assesment; Arm: Active Comparator: No Hemodynamic Monitored Guided Assesment This group will have the non-invasive hemodynamic monitoring device placed but its data will NOT be factored for intervention of the patient's management decisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of subjective assessment compared to device assessment of cardiac index	Comparison of cardiac index derived from subjective preoeprative assessment to cardiac index derived from device assessment	Up to one year from date of randomization

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: Edwards Lifesciences
• Investigators: Principal Investigator: Davinder Ramsingh, MD, Loma Linda University Health

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2016
• Primary Completion (Actual): June 14, 2021
• Study Completion (Actual): June 14, 2021

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 5160227

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.: Yes