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

This study has been completed.
Sponsor:
Collaborator:
BryTech, Inc.
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00664924
First received: April 21, 2008
Last updated: August 25, 2010
Last verified: August 2010
  Purpose

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
Physiological Monitoring
Critically Ill

Study Type: Observational
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)

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • measurement and accurate transmission of data [ Time Frame: June 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664924

Locations
Canada, Ontario
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
BryTech, Inc.
Investigators
Principal Investigator: Andrew Seely, MD Ottawa Hospital Research Institute
  More Information

No publications provided

Responsible Party: Dr. A Seely, OHRI
ClinicalTrials.gov Identifier: NCT00664924     History of Changes
Other Study ID Numbers: BRY-C-01-06-RPM, OHREB #2006712-01H
Study First Received: April 21, 2008
Last Updated: August 25, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
ICU

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014