Completed

NCT Number: NCT02300441

HI-VISION 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.

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Key information

Conditions

Postoperative Hypoxia

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Juravinski Hospital

Hamilton, Ontario, L8V5C2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ECG, blood pressure and oximetry

Other

Primary outcomes

Hypotension and Hypoxemia (baseline patterns and frequencies)

Time frame: 10 months

To identify baseline patterns and frequencies of hypotension and hypoxemia.

Secondary outcomes

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.
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.
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.
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.

Other outcomes

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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

Hamilton Health Sciences Corporation

Registry information

Official study title

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

Acronym: HI-VISION

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Nov 25, 2014
Registry last updated: Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.