Overview

This trial is active, not recruiting.

Condition postoperative hypoxia
Treatment ecg, blood pressure and oximetry
Sponsor McMaster University
Start date September 2014
End date September 2015
Trial size 133 participants
Trial identifier NCT02300441, HI-VISION Pilot Study

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Hypotension and Hypoxemia (baseline patterns and frequencies)
time frame: 10 months

Secondary Outcomes

Measure
Myocardial Ischemia (association between myocardial ischemia detected by the algorithm implemented by MX40 with Troponin I)
time frame: 10 months
Myocardial Ischemia (delay in detecting myocardial ischemia based on MX40 monitoring versus Troponin I monitoring)
time frame: 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
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

Eligibility Criteria

Male or female participants at least 45 years old.

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.

Additional Information

Official title HI-VISION - Hypotension Myocardial Ischemia-Vascular Events In Noncardiac Surgery Patients: a Cohort Evaluation: Pilot Study
Principal investigator Philip J. Devereaux, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by McMaster University.