Clinical trial NCT02300441: HI-VISION Pilot Study
Official title: HI-VISION - Hypotension Myocardial Ischemia-Vascular Events In Noncardiac Surgery Patients: a Cohort Evaluation: Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Hypoxia
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2014-11-25
Enrollment: 133
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hypotension and Hypoxemia (baseline patterns and frequencies)
timeFrame: 10 months
Secondary outcomes:
measure: Myocardial Ischemia (association between myocardial ischemia detected by the algorithm implemented by MX40 with Troponin I)
timeFrame: 10 months
measure: Myocardial Ischemia (delay in detecting myocardial ischemia based on MX40 monitoring versus Troponin I monitoring)
timeFrame: 10 months
measure: 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)
timeFrame: 10 months
measure: 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.)
timeFrame: 10 months
Other outcomes:
measure: Postoperative Pain (association between postoperative pain intensity and myocardial ischemia, nonfatal myocardial infarction, and cardiac mortality)
timeFrame: 10 months
Locations:
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Philip J. Devereaux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: