- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02300441
HI-VISION Pilot Study (HI-VISION)
HI-VISION - Hypotension Myocardial Ischemia-Vascular Events In Noncardiac Surgery Patients: a Cohort Evaluation: Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V5C2
- Juravinski Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip J. Devereaux, MD, PhD, McMaster University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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