Vital Sign MonitoringNCT03332147
Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients Patients
A study testing Investigational Group and reference group-Earlysense system in people with Vital Sign Monitoring, run by Darma Inc. at 3 sites in United States.
Trial summary
This study compares both of the investigational device and reference device to the gold standard Patient Monitor of the accuracy of heart rate and respiratory rate monitoring. The primary variables for the analysis of heart rate (HR) and respiratory rate (RR) are each of the overall mean roots mean square difference… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vital Sign Monitoring
- What is being tested?
- Investigational Group and reference group-Earlysense system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Nov 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female, 18 years old and above.
- Provide written informed consent.
- Weight ranging from 20 to 150 kg inclusive.
- Are located in a non-ICU hospital setting.
- Agree to not eat during the testing period.
- Agree to keep still.
Who cannot join
- Are connected to a device which may interfere with the device monitoring in this study.
- Are receiving any bedside care which may be incompatible with the study procedures.
- Sleep apnea.
- Pregnant or breastfeeding.
- A likely need to receive or undergo a procedure during the testing period.
- Cannot accept a nasal cannula, or have a monitor lead placed on the chest.
- A significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
- Are wearing pacemaker or defibrillator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Virginia Commonwealth University
Richmond, Virginia, 23298-0102
Medstar Health Research Institute
Washington D.C., District of Columbia, 20782
About this study
Official title: Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients
This study compares both of the investigational device and reference device to the gold standard Patient Monitor of the accuracy of heart rate and respiratory rate monitoring. The primary variables for the analysis of heart rate (HR) and respiratory rate (RR) are each of the overall mean roots mean square difference (RMSD). Results of the investigational device and reference device compared with the patient monitor is evaluated to see if there are equivalent. Motion and bed exit accuracy will be evaluated by comparing with the manual observation.
Read the detailed description
The testing will be conducted in three periods. In the Accuracy Tests (periods
1 and 2), one of the contact-free devices will be used to monitor the HR and RR, while being compared with the Patient Monitor. The RHEA investigational device and reference device will be used to monitor the same subject at different times, as the sensors of the two devices are placed at a similar location of the bed. HR and RR will be recorded for all three devices.
The primary hypotheses for HR, are as follows:
Adults HO: μ = 3.25 vs. HA: μ < 3.25
The primary hypotheses for RR, are as follows:
Adults HO: μ = 2.25 vs. HA: μ < 2.25 where μ represents the population mean HR or RR. If the upper bound of the confidence interval is less than the hypothesized value, the corresponding null hypothesis will be rejected. Comparison of the performance of the two contract-free devices will be performed on the recorded results via statistical analysis. The hypothesis here is that the two devices have equivalent performance. The third test will assess the ability of the RHEA device to accurately detect motion in or exit from the bed, as compared to the manual observation. Motion and no motion accuracy will each be calculated along with their respective two-sided 95% confidence intervals.
- Conditions
- Vital Sign Monitoring
- Being tested
- Investigational Group, reference group-Earlysense system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational GroupDevice
The RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
reference group-Earlysense systemDevice
The reference device Earlysense 2.0 system(vital sign monitoring system) and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Group | Experimental | The RHEA device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants. Receives: Device: Investigational Group |
| reference group-Earlysense system | Active comparator | The reference device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants. Receives: Device: reference group-Earlysense system |
What is being measured
The primary outcome is the main question the study is designed to answer.
RMSD of Investigational Device's Heart Rate and Gold Standard Device's heart rate
Record 20 valid pair heart rate displayed in the investigational device and patient monitor at the same time every one minutes.Calculate the root mean square difference(RMSD) of the heart rate for the investigational device and the gold standard device.
Measured: 45 days
RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory rate
Record 20 valid pair respiratory rate displayed in the investigational device and patient monitor at the same time every one minutes.Calculate the root mean square difference(RMSD) of the respiratory rate for the investigational device and the gold standard device.
Measured: 45 days
Secondary outcomes (4)
Heart Rate t Test Comparison result between the Investigational Device and the Reference Device
Record 20 valid heart rate displayed in the reference device and patient monitor at the same time every one minute.
Calculate the t test results for heart rate for the reference device and the investigational device.
Measured: 45 days
Respiratory Rate t Test Comparison result between the Investigational Device and the reference device
Record 20 valid respiratory rate displayed in the reference device and patient monitor at the same time every one minute. Calculate the t test results for respiratory rate for the reference device and the investigational device.
Measured: 45 days
Motion Notification Accuracy(%)
Record the time for each instructed movements from manual observation and time for movements notification shown in the investigational device. Calculate the times matched between these two to get the accuracy.
Measured: 45 days
Bed Exit Notification Accuracy(%)
Record the time for each instructed bed exit from manual observation and time for bed exit notification shown in the investigational device. Calculate the times matched between these two to get the accuracy.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start4 Nov 2017
- Primary completion25 May 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Sign MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The reference device and Patient Monitor are used to monitor the heart rate (HR) and respiratory rate (RR) of the same participant at the same time in Test 1. The RHEA device and patient monitor are used to monitor the heart rate and respiratory rate of the same participant at the same time in Test 2. The two tests results will be compared and evaluated for the accuracy of the two devices. The RHEA device is used alone to evaluate the accuracy of motion or no motion alarm in Test 3.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Darma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tufts Medical Center, Medstar Health Research Institute, Virginia Commonwealth University
- Responsible party
- Sponsor
- Investigators
- Judith Cullinane, MSN, Principal investigator, Tufts Medical CenterArrel Olano, MD, Principal investigator, Medstar Health Research InstituteRehan Qayyum, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332147
- Sponsor's protocol ID
- RHEA EL30-2017-001
- Status last verified
- Apr 2019
- First submitted
- 27 Oct 2017
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients
- ClinicalTrials.gov ID
- NCT03332147
- Acronym / sponsor ID
- RHEA EL30-2017-001
- Conditions
- Vital Sign Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Darma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tufts Medical Center, Medstar Health Research Institute, Virginia Commonwealth University
- Study start
- 4 Nov 2017 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares both of the investigational device and reference device to the gold standard Patient Monitor of the accuracy of heart rate and respiratory rate monitoring. The primary variables for the analysis of heart rate (HR) and respiratory rate (RR) are each of the overall mean roots mean square difference (RMSD). Results of the investigational device and reference device compared with the patient monitor is evaluated to see if there are equivalent. Motion and bed exit accuracy will be evaluated by comparing with the manual observation.
Detailed description
The testing will be conducted in three periods. In the Accuracy Tests (periods
1 and 2), one of the contact-free devices will be used to monitor the HR and RR, while being compared with the Patient Monitor. The RHEA investigational device and reference device will be used to monitor the same subject at different times, as the sensors of the two devices are placed at a similar location of the bed. HR and RR will be recorded for all three devices.
The primary hypotheses for HR, are as follows:
Adults HO: μ = 3.25 vs. HA: μ < 3.25
The primary hypotheses for RR, are as follows:
Adults HO: μ = 2.25 vs. HA: μ < 2.25 where μ represents the population mean HR or RR. If the upper bound of the confidence interval is less than the hypothesized value, the corresponding null hypothesis will be rejected. Comparison of the performance of the two contract-free devices will be performed on the recorded results via statistical analysis. The hypothesis here is that the two devices have equivalent performance. The third test will assess the ability of the RHEA device to accurately detect motion in or exit from the bed, as compared to the manual observation. Motion and no motion accuracy will each be calculated along with their respective two-sided 95% confidence intervals.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The reference device and Patient Monitor are used to monitor the heart rate (HR) and respiratory rate (RR) of the same participant at the same time in Test 1. The RHEA device and patient monitor are used to monitor the heart rate and respiratory rate of the same participant at the same time in Test 2. The two tests results will be compared and evaluated for the accuracy of the two devices. The RHEA device is used alone to evaluate the accuracy of motion or no motion alarm in Test 3.
| Arm | Type | Receives |
|---|---|---|
| Investigational Group | Experimental | Device: Investigational GroupThe RHEA device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants. |
| reference group-Earlysense system | Active comparator | Device: reference group-Earlysense systemThe reference device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, 18 years old and above.
- Provide written informed consent.
- Weight ranging from 20 to 150 kg inclusive.
- Are located in a non-ICU hospital setting.
- Agree to not eat during the testing period.
Key exclusion criteria (8 listed)
- Are connected to a device which may interfere with the device monitoring in this study.
- Are receiving any bedside care which may be incompatible with the study procedures.
- Sleep apnea.
- Pregnant or breastfeeding.
- A likely need to receive or undergo a procedure during the testing period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational GroupThe RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants. | Device | Investigational Group |
| reference group-Earlysense systemThe reference device Earlysense 2.0 system(vital sign monitoring system) and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants. | Device | reference group-Earlysense system |
Primary outcome
RMSD of Investigational Device's Heart Rate and Gold Standard Device's heart rate
Time frame: 45 days
Record 20 valid pair heart rate displayed in the investigational device and patient monitor at the same time every one minutes.Calculate the root mean square difference(RMSD) of the heart rate for the investigational device and the gold standard device.
RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory rate
Time frame: 45 days
Record 20 valid pair respiratory rate displayed in the investigational device and patient monitor at the same time every one minutes.Calculate the root mean square difference(RMSD) of the respiratory rate for the investigational device and the gold standard device.
4 secondary outcomes
Heart Rate t Test Comparison result between the Investigational Device and the Reference Device
Time frame: 45 days
Respiratory Rate t Test Comparison result between the Investigational Device and the reference device
Time frame: 45 days
Motion Notification Accuracy(%)
Time frame: 45 days
Bed Exit Notification Accuracy(%)
Time frame: 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Cullinane, MSN principal investigator
Tufts Medical Center
Arrel Olano, MD principal investigator
Medstar Health Research Institute
Rehan Qayyum, MD principal investigator
Virginia Commonwealth University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Group and reference group-Earlysense system in people with Vital Sign Monitoring, run by Darma Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RMSD of Investigational Device's Heart Rate and Gold Standard Device's heart rate (time frame: 45 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.