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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00664924
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : January 23, 2017
BryTech, Inc.
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief 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.

Condition or disease
Physiological Monitoring Critically Ill

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Study Type : Observational
Actual Enrollment : 40 participants
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)
Study Start Date : October 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Primary Outcome Measures :
  1. measurement and accurate transmission of data [ Time Frame: June 2008 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cohort 1 (Exercise): patients who are scheduled to undergo a minimum of 20 minutes of exercise testing.

Cohort 2 (ICU): patients admitted to the Intensive Care Unit (ICU) Cohort 3 (Post-op): patients in Post-Operative care Cohort 4 (ER): patients admitted to the Emergency Room (e.g., high risk medical admissions) These cohorts are considered representative of a broad spectrum of the general patient population. Patients participating in the study will be assigned to one of these 4 cohorts, with a minimum of 10 patients assigned to Cohort 1 (Exercise) and a minimum of 5 patients in each of the other cohorts.


Inclusion Criteria:

  1. The informed consent document must be read, signed, and dated by the patient (or legally authorized representative), the individual obtaining the consent, and a witness if appropriate, before conducting any study related procedures or examinations.
  2. Patients will be ≥18 years of age or older, of any race and either sex. Women who are pregnant may participate in the study.
  3. The RPM™ must not interfere with patient care.
  4. Investigator or Study Staff must be able to clearly access the sites for attaching sensors.

Specific Inclusion Criteria for Cohort 1 (Exercise):

  • Patients who are referred for Stage-I pre-operative exercise testing to assess fitness for surgery.
  • Patients who have a history of a chronic respiratory or cardiac condition resulting in symptoms with exertion.

Specific Inclusion Criteria for Cohort 2 (ICU):

� Patients admitted to the ICU on life support whose hospital stay is expected to be more than 72 hours.

Specific Inclusion Criteria for Cohort 3 (Post-op):

  • Patients undergoing surgery and post-operative recovery are expected to be more than 72 hours.
  • A broad variety of patients with a history of coronary heart disease, congestive heart failure or chronic lung disease, and considered at high risk of cardiopulmonary complications; or patients who have undergone major thoracic surgery with a high risk of cardiopulmonary complications.

Specific Inclusion Criteria for Cohort 4 (ER):

� Patients who are admitted to a general medical ward from the ER whose hospital stay is expected to be more than 72 hours.

Exclusion Criteria:

  1. Patients with a history of any medical condition which would preclude completion of the study, e.g., patients whose skin disorders or excessive weight interfere with the proper functioning of standard monitoring.
  2. Patients with significant unstable disease that could compromise the study assessments and/or participation in the study.
  3. The PI or the Medical Monitor may declare a patient ineligible for a valid medical reason or where the patient's condition or patient's actions may be inappropriate for inclusion in a study of this design.

Specific Exclusion Criteria for Cohort 1 (Exercise):

  • Patients who would not tolerate a standard exercise test such as patients who have severe peripheral vascular disease, disabling arthritis or neurological condition;
  • Patients who have had a significant change in symptoms since referral (e.g., unstable angina, recent myocardial infarction).

Specific Exclusion Criteria for Cohort 2 (ICU), 3, & 4:

  • Patients who are severely agitated;
  • Patients where increased monitoring may interfere with the provision of clinical care;
  • Patients where the family or the attending team are not committed to providing all necessary aggressive supportive care;
  • Patients who are considered brain dead;
  • Patients where standard sensors are not capturing such as unstable patients with severe peripheral vascular disease where saturation probes do not function properly.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00664924

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Canada, Ontario
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
BryTech, Inc.
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Principal Investigator: Andrew Seely, MD Ottawa Hospital Research Institute
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Responsible Party: Ottawa Hospital Research Institute Identifier: NCT00664924    
Other Study ID Numbers: BRY-C-01-06-RPM
OHREB #2006712-01H ( Other Identifier: Ottawa Hospital Research Ethics Boards )
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Keywords provided by Ottawa Hospital Research Institute:
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes