Comparative in Patient, Non-intervention Study of the Remote Physiological Monitoring System (RPM�) vs Standard Physiological Monitoring Devices
The Remote Physiological Monitoring System (RPM�) is a wireless technology for physiological monitoring. The RPM� is designed to capture, transmit and remotely monitor the vital signs of a patient or group of patients. The RPM� allows the patient to carry an unobtrusive unit and sensor array, which is able to store and/or forward its data via existing communication networks. This data is archivable and can be made available to a monitoring station or stations. This approach obviates the need to provide new and expensive infrastructure to support the system since it is designed to �piggy-back� on the existing network.
A major clinical advantage of the RPM� and the principal reason why it may offer a benefit to patients, is that it provides continuous remote monitoring of vital signs, in contrast to the current situation for ward patients, where there is intermittent vital signs monitoring. This is a major advantage for patients and hospital staff, since there is increasing evidence that demonstrate early recognition and treatment of clinical events, e.g., shock, can save lives; the concurrent cost and labour saving is a further obvious benefit.
The RPM� uses wireless technology to overcome the portability problems associated with conventional patient monitoring systems. The RPM� consists of the following system components:
- Physiological Monitoring Unit (PMU)
- Data Aggregation Server (DAS)
- Clinical Monitoring Position (CMP) To validate the RPM� device for regulatory approval, BRYTECH will evaluate the RPM� in a clinical setting, thereby ensuring that the system is trustworthy and acceptable to health professionals as a monitoring system in patients. The study proposes to evaluate the accuracy and reliability of the RPM� compared to monitors commonly used in the medical practice under the standard conditions of medical practice The study also proposes to evaluate notification and alarm systems, the communications interface and non-interference with existing systems, devices, networks and procedures as well as the incremental nursing workload associated with the integration of the RPM� in a clinical environment. The RPM� and reference physiological monitoring devices will be compared for physiological monitoring capabilities in 40 patients.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Comparative In-patient, Non-intervention Study of the Remote Physiological Monitoring System (RPM�), a Non-invasive, Remote, Ambulatory Vital Signs Monitoring Device, Versus Standard Physiological Monitoring Devices by Simultaneous Monitoring of Heart Rate, ECG, SpO2, Blood Pressure, Body Temperature, and Respiration Rate in a 24 hr Monitoring Period (BRYTECH #BRY-C-01-06-RPM)|
- measurement and accurate transmission of data [ Time Frame: June 2008 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00664924
|The Ottawa Hospital, General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||Andrew Seely, MD||Ottawa Hospital Research Institute|