HI-VISION Pilot Study

McMaster University133 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

133

Conditions

Postoperative Hypoxia

Interventions

ECG, blood pressure and oximetryOTHER

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Juravinski Hospital

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Hypotension and Hypoxemia (baseline patterns and frequencies)

To identify baseline patterns and frequencies of hypotension and hypoxemia.

Time frame: 10 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 10 months

Data from ClinicalTrials.gov

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