HI-VISION Pilot Study (HI-VISION)

April 20, 2018 updated by: McMaster University

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

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Hamilton, Ontario, Canada, L8V5C2
        • Juravinski Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 45 or greater who present for noncardiac surgery with 2 or more risk factors for heart disease and will be receiving a general or spinal anesthesia with an anticipated length of stay of 3 days or more.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypotension and Hypoxemia (baseline patterns and frequencies)
Time Frame: 10 months
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)
Time Frame: 10 months
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)
Time Frame: 10 months
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)
Time Frame: 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.
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.)
Time Frame: 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.
10 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain (association between postoperative pain intensity and myocardial ischemia, nonfatal myocardial infarction, and cardiac mortality)
Time Frame: 10 months
To determine the association between postoperative pain intensity and myocardial ischemia, nonfatal myocardial infarction, and cardiac mortality.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Philip J. Devereaux, MD, PhD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 25, 2014

Study Record Updates

Last Update Posted (Actual)

April 24, 2018

Last Update Submitted That Met QC Criteria

April 20, 2018

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HI-VISION Pilot Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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