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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02950649
Enrollment
189
Registered
2016-11-01
Start date
2016-11-17
Completion date
2021-06-14
Last updated
2022-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Monitoring

Brief 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.

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.

Interventions

DEVICEinvasive 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).

DEVICENo 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.

Sponsors

Edwards Lifesciences
CollaboratorINDUSTRY
Loma Linda University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of subjective assessment compared to device assessment of cardiac indexUp to one year from date of randomizationComparison of cardiac index derived from subjective preoeprative assessment to cardiac index derived from device assessment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026