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HI-VISION Pilot Study (HI-VISION)

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ClinicalTrials.gov Identifier: NCT02300441
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment
Postoperative Hypoxia Other: ECG, blood pressure and oximetry

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.


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Study Type : Observational
Actual Enrollment : 133 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HI-VISION - Hypotension Myocardial Ischemia-Vascular Events In Noncardiac Surgery Patients: a Cohort Evaluation: Pilot Study
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Hypotension and Hypoxemia (baseline patterns and frequencies) [ Time Frame: 10 months ]
    To identify baseline patterns and frequencies of hypotension and hypoxemia.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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 Outcome Measures:
  1. 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.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300441


Locations
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Canada, Ontario
Juravinski Hospital
Hamilton, Ontario, Canada, L8V5C2
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: Philip J. Devereaux, MD, PhD McMaster University

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02300441     History of Changes
Other Study ID Numbers: HI-VISION Pilot Study
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: March 2016

Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms