Ignite Creation Date:
2024-05-05 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 9:48 AM
Study NCT ID:
NCT00664924
Status:
COMPLETED
Last Update Posted:
2017-01-23
First Post:
2008-04-21
Brief Title:
Comparative in Patient Non-intervention Study of the Remote Physiological Monitoring System RPM vs Standard Physiological Monitoring Devices
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 eg 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
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 eg 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
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 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 andor 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 eg 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 uses off the shelf computer technology such as standard displays as well as secure wireless 80211 networking protocols and 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 this study will therefore be a non-intervention study 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 from the following four 4 cohorts
1 Cohort 1 Exercise patients who are scheduled to undergo a minimum of 20 minutes of exercise testing
2 Cohort 2 ICU patients admitted to the Intensive Care Unit ICU
3 Cohort 3 Post-op patients in Post-Operative care
4 Cohort 4 ER patients admitted to the Emergency Room eg 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
For the study the RPM and reference monitoring devices will be time-stamped such that zero time will be readily evaluable and patients will be fitted with all necessary sensors for collection of vital signs namely heart rate HR electrocardiogram ECG blood oxygen saturation levels SpO2 non-invasive blood pressure NIBP body temperature BT and respiration rate RR
For Cohort 1 Exercise patients comparative monitoring of vital signs will be done during exercise testing for a minimum of 20 minutes with additional monitoring performed pre- and post-exercise There will be a minimum of 10 patients in this cohort For patients in Cohorts 2 3 and 4 comparative monitoring of vital signs will be performed during the period 24 - 72 hours required to collect 12 Vital Sign Assessment Cycles VSAC - defined in Section 522 per subject with a minimum of 5 patients in each cohort and a total of 30 patients The four cohorts of patients have been chosen to allow comparison of vital signs from the RPM and standard nursing measurement techniques over a broad range of physiologic data eg rest and exercise and patient populations eg stable and critically illThe primary objective for the study is to determine substantial equivalence of the RPM and the reference devices or standard practice measurements by comparing the agreement accuracy between paired output results for individual vital signs and the reliability of data collection over a 24 hour monitoring period Timepoint matched paired data for all available timepoints will be collected from the RPM and the reference devices excluding ambulatory data for heart rate ECG SpO2 blood pressure body temperature and respiration rate Accuracy will be determined by assessing whether the paired values show significant agreement Reliability will be determined by a comparison of cumulative totals for lost data points and error rates
The study will be conducted according to Good Clinical Practice GCP guidelines with all patients required to sign an Informed Consent Form ICF This is a non-intervention study and patients tested will be subjected to use of the RPM as the only experimental procedure during the trial Importantly patients will not be exposed to any significant risks as a result of participating in this study
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 andor 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 eg 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 uses off the shelf computer technology such as standard displays as well as secure wireless 80211 networking protocols and 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 this study will therefore be a non-intervention study 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 from the following four 4 cohorts
1 Cohort 1 Exercise patients who are scheduled to undergo a minimum of 20 minutes of exercise testing
2 Cohort 2 ICU patients admitted to the Intensive Care Unit ICU
3 Cohort 3 Post-op patients in Post-Operative care
4 Cohort 4 ER patients admitted to the Emergency Room eg 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
For the study the RPM and reference monitoring devices will be time-stamped such that zero time will be readily evaluable and patients will be fitted with all necessary sensors for collection of vital signs namely heart rate HR electrocardiogram ECG blood oxygen saturation levels SpO2 non-invasive blood pressure NIBP body temperature BT and respiration rate RR
For Cohort 1 Exercise patients comparative monitoring of vital signs will be done during exercise testing for a minimum of 20 minutes with additional monitoring performed pre- and post-exercise There will be a minimum of 10 patients in this cohort For patients in Cohorts 2 3 and 4 comparative monitoring of vital signs will be performed during the period 24 - 72 hours required to collect 12 Vital Sign Assessment Cycles VSAC - defined in Section 522 per subject with a minimum of 5 patients in each cohort and a total of 30 patients The four cohorts of patients have been chosen to allow comparison of vital signs from the RPM and standard nursing measurement techniques over a broad range of physiologic data eg rest and exercise and patient populations eg stable and critically illThe primary objective for the study is to determine substantial equivalence of the RPM and the reference devices or standard practice measurements by comparing the agreement accuracy between paired output results for individual vital signs and the reliability of data collection over a 24 hour monitoring period Timepoint matched paired data for all available timepoints will be collected from the RPM and the reference devices excluding ambulatory data for heart rate ECG SpO2 blood pressure body temperature and respiration rate Accuracy will be determined by assessing whether the paired values show significant agreement Reliability will be determined by a comparison of cumulative totals for lost data points and error rates
The study will be conducted according to Good Clinical Practice GCP guidelines with all patients required to sign an Informed Consent Form ICF This is a non-intervention study and patients tested will be subjected to use of the RPM as the only experimental procedure during the trial Importantly patients will not be exposed to any significant risks as a result of participating in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OHREB 2006712-01H | OTHER | Ottawa Hospital Research Ethics Boards | None |