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

Hemodynamic Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02950649
• Other study ID #: 5160227
• Status: Terminated
• Start date: November 17, 2016
• Est. completion date: June 14, 2021

Study information

• Verified date: April 2022
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 189
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Monitoring

Intervention

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
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.

Locations

Country	Name	City	State
United States	Loma Linda Health	Loma Linda	California
United States	Loma Linda University Department of Anesthesiology	Loma Linda	California
United States	Pat Moore	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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