Hypotension Prediction Index in Postoperative Surgical Patients

Study Overview
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Brief Summary
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PACU-HPI study evaluates the use of a hemodynamic monitor in the post-anesthetic recovery room on patients undergoing colorectal, hepatobiliary, and vascular surgery, to determine the feasibility of recruiting this surgical population.

Detailed Description
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Postoperative vascular complications, including myocardial infarction (MI), myocardial injury after noncardiac surgery (MINS), stroke, and death occur in up to 18% of surgical patients.1 Hypotension is a frequent occurrence in the postoperative period and can increase the risk of postoperative vascular complications.2 Therefore, accurate prediction of postoperative hypotension can identify patients at risk for postoperative vascular complications who would benefit from early intervention. The investigators propose a feasibility study to determine the accuracy of the hypotension prediction index (HPI) parameter of the HemoSphere monitor and Acumen IQ sensor (Edwards Lifesciences, Irvine, CA) to predict postoperative hypotension in surgical patients.

Official Title
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Hypotension Prediction Index in Postoperative Surgical Patients in the Post-anesthetic Recovery Room - a Feasibility Study

Conditions
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Surgery

Intervention / Treatment
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* Device: Device: HemoSphere monitor and Acumen IQ sensor.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ≥45 years old Will undergo open colorectal, hepatobiliary, or vascular surgery; Is expected to have an arterial cannula inserted intraoperatively; Has an anticipated stay in PACU for at least 2 hours; Able to provide written informed consent Exclusion Criteria: Planned admission to ICU; Refusal to participate; Previously enrolled in the study

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HPI monitor<br> | Device: Device: HemoSphere monitor and Acumen IQ sensor.<br>* Patients will be placed on this monitor for the duration of study in the PACU. Followed by 30-day phone call to record cardiovascular complications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative hypotension | Describe the incidence of hypotension defined as MAP <65 intraoperatively. | in 12 months | 
| Incidence of postoperative hypotension | Describe the incidence of postoperative hypotension defined as MAP <65 in the PACU | in 12 months | 
| Hemodynamic changes with treatment of hypotension | Described the changes in cardiac index with each medical treatment of a hypotensive episode. | in 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of HPI | Sensitivity and Specificity of HPI compared to a hypotensive events in the postoperative setting | in 12 months | 
| Cardiovascular outcomes | Number of patients with Mortality, MI, MINS, acute pulmonary edema, stroke, pulmonary embolism, deep vein thrombosis | in 12 months |