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
| Type | Name | Description |
|---|---|---|
| DEVICE | Remote ECG monitoring Spacelab SL 1050 | If 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.