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HI-VISION Pilot Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02300441
Acronym
HI-VISION
Enrollment
133
Registered
2014-11-25
Start date
2014-09-30
Completion date
2015-09-30
Last updated
2018-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Hypoxia

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.

Interventions

OTHERECG, blood pressure and oximetry

Sponsors

Hamilton Health Sciences Corporation
CollaboratorOTHER
McMaster University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Hypotension and Hypoxemia (baseline patterns and frequencies)10 monthsTo identify baseline patterns and frequencies of hypotension and hypoxemia.

Secondary

MeasureTime frameDescription
Myocardial Ischemia (association between myocardial ischemia detected by the algorithm implemented by MX40 with Troponin I)10 monthsTo 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)10 monthsTo 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 monthsTo 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.)10 monthsTo 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

MeasureTime frameDescription
Postoperative Pain (association between postoperative pain intensity and myocardial ischemia, nonfatal myocardial infarction, and cardiac mortality)10 monthsTo determine the association between postoperative pain intensity and myocardial ischemia, nonfatal myocardial infarction, and cardiac mortality.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026