HI-VISION Pilot Study

Study Overview
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Brief Summary
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A prospective cohort pilot study of non-cardiac patients to determine the feasibility of recruiting 150 patients to undergo postoperative continuous hemodynamic monitoring for up to 3 days.

Detailed Description
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Patient will start wearing the Philips' hemodynamic and ECG monitor in the Post Anaesthesia Care Unit (PACU). This device will continuously measure heart rate, pulse oxymetry, and ST-segments. The device will measure blood pressure every hour from 7 am to 10 pm and every 2 hours from 10 pm to 7 am. Patients will have postoperative Troponin I monitoring and telephone follow-up at 30 days postop.

Official Title
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HI-VISION - Hypotension Myocardial Ischemia-Vascular Events In Noncardiac Surgery Patients: a Cohort Evaluation: Pilot Study

Conditions
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Postoperative Hypoxia

Intervention / Treatment
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* Other: ECG, blood pressure and oximetry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: We will enroll patients aged 45 years or older undergoing noncardiac surgery who fulfilled 2 or more of the following risk factors: History of coronary artery disease History of stroke or transient ischemic attack (TIA) History of hypertension History of diabetes History of peripheral vascular disease History of congestive heart failure Preoperative creatinine > 175 umol/L A planned admission for ≥48 hours Patients receiving a general or regional anesthetic Exclusion Criteria: Patients unable to provide informed consent. Patients who undergo procedure performed under infiltrative or topical anesthesia. Patients previously enrolled in the HI-VISION Study. Patients who refuse 30-day follow-up.

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

| Intervention/Treatment |
| --- |
|Other: ECG, blood pressure and oximetry|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension and Hypoxemia (baseline patterns and frequencies) | To identify baseline patterns and frequencies of hypotension and hypoxemia. | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Ischemia (association between myocardial ischemia detected by the algorithm implemented by MX40 with Troponin I) | To determine the association between myocardial ischemia detected by the algorithm implemented by MX40 with Troponin I. | 10 months | 
| Myocardial Ischemia (delay in detecting myocardial ischemia based on MX40 monitoring versus Troponin I monitoring) | To determine the delay in detecting myocardial ischemia based on MX40 monitoring versus Troponin I monitoring. | 10 months | 
| Myocardial Ischemia (number of patients with missed clinically important hypotension, bradycardia, and hypoxia based on routine monitoring in clinical practice versus remote, automated, non-invasive hemodynamic monitoring) | To determine the number of patients with missed clinically important hypotension, bradycardia, and hypoxia based on routine monitoring in clinical practice versus remote, automated, non-invasive hemodynamic monitoring. | 10 months | 
| Myocardial Ischemia (delay in detecting clinically important hypotension, bradycardia, and hypoxia based on routine monitoring in clinical practice versus remote, automated, non-invasive hemodynamic monitoring.) | To determine the delay in detecting clinically important hypotension, bradycardia, and hypoxia based on routine monitoring in clinical practice versus remote, automated, non-invasive hemodynamic monitoring. | 10 months |