HI-VISION Pilot Study

Postoperative Hypoxia Clinical Trial

— HI-VISION  

Official title:

HI-VISION - Hypotension Myocardial Ischemia-Vascular Events In Noncardiac Surgery Patients: a Cohort Evaluation: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300441
• Other study ID #: HI-VISION Pilot Study
• Status: Completed
• First received: October 20, 2014
• Last updated: April 20, 2018
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxia
• Postoperative Hypoxia

Intervention

Other:
• ECG, blood pressure and oximetry

Locations

Country	Name	City	State
Canada	Juravinski Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative Pain (association between postoperative pain intensity and myocardial ischemia, nonfatal myocardial infarction, and cardiac mortality)	To determine the association between postoperative pain intensity and myocardial ischemia, nonfatal myocardial infarction, and cardiac mortality.	10 months
Primary	Hypotension and Hypoxemia (baseline patterns and frequencies)	To identify baseline patterns and frequencies of hypotension and hypoxemia.	10 months
Secondary	Myocardial Ischemia (association between myocardial ischemia detected by the algorithm implemented by MX40 with Troponin I)	To determine the association between myocardial ischemia detected by the algorithm implemented by MX40 with Troponin I.	10 months
Secondary	Myocardial Ischemia (delay in detecting myocardial ischemia based on MX40 monitoring versus Troponin I monitoring)	To determine the delay in detecting myocardial ischemia based on MX40 monitoring versus Troponin I monitoring.	10 months
Secondary	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)	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
Secondary	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.)	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