Clinical Trials Directory

Trials / Completed

CompletedNCT01423136

Remote Electrocardiographic (ECG) ST-Monitoring (PROSE 3)in Post-op Patients

Postop Remote ECG ST-Monitoring (PROSE 3)

Status
Completed
Phase
Study type
Observational
Enrollment
89 (actual)
Sponsor
Ottawa Hospital Research Institute · Academic / Other
Sex
All
Age
55 Years
Healthy volunteers
Not accepted

Summary

In moderate to high risk patients, cardiovascular complications after surgery account for almost 60% of death after surgery. This study will randomize 140 patients into routine postop care with Holter monitoring versus routine postop care + remote ST monitoring + Holter monitoring. The response time to electrocardiographic (ECG) ST changes as well as the total ischemia time will be studied.

Detailed description

This proposal aims to improve the process and quality of care in the postoperative period by early detection of ischemia and prompt use of accepted therapies in order to prevent postoperative myocardial infarctions (PMI) in patients undergoing non-cardiac surgery. Specifically, it aims to validate the safety and efficacy of wireless remote real-time ECG ST-monitoring in the reduction of the incidence of PMI. It extends two pilot feasibility studies into the postoperative period using wireless remote ST-monitoring for early detection of myocardial ischemia followed by preventative strategies. It is anticipated that this research will improve postoperative care by adopting generalizable and practical strategies.

Conditions

Interventions

TypeNameDescription
DEVICERemote ECG monitoring Spacelab SL 1050If ischemia noted, Sx will be notified and currently accepted treatments of myocardial ischemia will be recommended.

Timeline

Start date
2010-10-01
Primary completion
2012-03-01
Completion
2012-10-01
First posted
2011-08-25
Last updated
2014-06-02

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01423136. Inclusion in this directory is not an endorsement.