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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:12/19/2018
Start Date:November 2016
End Date:July 25, 2019
Contact:Davinder Ramsingh, MD
Email:dramsingh@llu.edu
Phone:909-558-4475

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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.

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.

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%-
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4. history of Raynaud's,

5. refusal to provide written consent
We found this trial at
3
sites
Loma Linda, California 92354
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11092 Anderson Street
Loma Linda, California 92350
Phone: 909-558-4475
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Loma Linda, California 92354
Principal Investigator: Davinder Ramsingh, MD
Phone: 909-558-4475
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