Status:
COMPLETED
Comparative in Patient, Non-intervention Study of the Remote Physiological Monitoring System (RPM™) vs Standard Physiological Monitoring Devices
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
BryTech, Inc.
Conditions:
Physiological Monitoring
Critically Ill
Eligibility:
All Genders
18+ years
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 ...
Detailed Description
BRYTECH 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...
Eligibility Criteria
Inclusion
- 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.
- Patients will be ≥18 years of age or older, of any race and either sex. Women who are pregnant may participate in the study.
- The RPM™ must not interfere with patient care.
- 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
- 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.
- Patients with significant unstable disease that could compromise the study assessments and/or participation in the study.
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00664924
Start Date
October 1 2007
End Date
December 1 2008
Last Update
January 23 2017
Active Locations (1)
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1
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H 8L6