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Comparative in Patient, Non-intervention Study of the Remote Physiological Monitoring System (RPM™) vs Standard Physiological Monitoring Devices

NCT00664924 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2017-01-23

No results posted yet for this study

Summary

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:

1. Physiological Monitoring Unit (PMU)
2. Data Aggregation Server (DAS)
3. 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.

Conditions

  • Physiological Monitoring
  • Critically Ill

Sponsors & Collaborators

  • BryTech, Inc.

    collaborator INDUSTRY

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Andrew Seely, MD · Ottawa Hospital Research Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00664924 on ClinicalTrials.gov