Clinical trial NCT02950649: Evaluation of Clinical Impact of Non-Invasive Hemodynamic Monitoring to Optimize Perioperative Care
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hemodynamic Monitoring
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2016-11-01
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult subjects with ASA classification level 3 and 4, with less than 5 metabolic events

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of subjective assessment compared to device assessment of cardiac index
timeFrame: Up to one year from date of randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Health
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Department of Anesthesiology
state: California
city: Loma Linda
country: United States
facility: Pat Moore
state: California
Study officials:
affiliation: Loma Linda University Health
name: Davinder Ramsingh, MD
role: PRINCIPAL_INVESTIGATOR
References: