HI-VISION Pilot Study

NCT ID: NCT02300441

Last Updated: 2018-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Postoperative Hypoxia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ECG, blood pressure and oximetry

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip J. Devereaux, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Juravinski Hospital

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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HI-VISION Pilot Study

Identifier Type: -

Identifier Source: org_study_id

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