HI-VISION Pilot Study

Completed

• Conditions: Postoperative Hypoxia

• Registration Number: NCT02300441
• Lead Sponsor: McMaster University

Brief Summary

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

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-25
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-03
• Last Update Submitted: 2018-04-20
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hypotension and Hypoxemia (baseline patterns and frequencies)	10 months	To identify baseline patterns and frequencies of hypotension and hypoxemia.

Secondary Outcome Measures

Name	Time	Method
Myocardial Ischemia (association between myocardial ischemia detected by the algorithm implemented by MX40 with Troponin I)	10 months	To determine the association between myocardial ischemia detected by the algorithm implemented by MX40 with Troponin I.
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.)	10 months	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.
Myocardial Ischemia (delay in detecting myocardial ischemia based on MX40 monitoring versus Troponin I monitoring)	10 months	To determine the delay in detecting myocardial ischemia based on MX40 monitoring versus Troponin I monitoring.
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)	10 months	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.

Trial Locations

Locations (1)

Juravinski Hospital; 🇨🇦 Hamilton, Ontario, Canada