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Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients

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.
 
ClinicalTrials.gov Identifier: NCT03356184
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Virginia Commonwealth University
Information provided by (Responsible Party):
Darma Inc.

Study Description
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Brief 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 (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.

Condition or disease Intervention/treatment Phase
Vital Sign Monitoring Device: The Rhea Vital Sign Vigilance Device Group Device: The Earlysense System Device Group Not Applicable

Detailed Description:

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The RHEA device and Patient Monitor are used to monitor the heart rate (HR) and respiratory rate (RR) of participants at the same time in Test 1. The reference 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 the accuracy of the two devices. And the RHEA device is used alone to evaluate the accuracy of motion and no motion.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients
Actual Study Start Date : May 11, 2018
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs

Arms and Interventions
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Arm Intervention/treatment
Experimental: The Rhea Vital Sign Vigilance Device Group
The RHEA device and Philips Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
 Device: The Rhea Vital Sign Vigilance Device Group
The RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
Active Comparator: The Earlysense System Device Group
The reference device -EarlySense System and Philips Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
 Device: The Earlysense System Device Group
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.


Outcome Measures
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Primary Outcome Measures :
  1. Root-mean-square Deviation of Heart Rate [ Time Frame: 30 days ]
    Calculate the root-mean-square deviation (RMSD) of the heart rate using 20 pairs of valid and synchronously recorded heart rate of investigational device and patient monitor.

  2. Root-mean-square Deviation of Respiratory Rate [ Time Frame: 30 days ]
    Calculate the root-mean-square deviation (RMSD) of the respiratory rate using 20 pairs of valid and synchronously recorded respiratory rate of investigational device and patient monitor.


Secondary Outcome Measures :
  1. Heart Rate t Test Comparison result between the Investigational Device and the Reference Device [ Time Frame: 30 days ]

    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.


  2. Respiratory Rate t Test Comparison result between the Investigational Device and the Reference Device [ Time Frame: 30 days ]
    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.

  3. Motion Notification Accuracy(%) [ Time Frame: 30 days ]
    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.

  4. Bed Exit Notification Accuracy(%) [ Time Frame: 30 days ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18 years old and above.
  2. Provide written informed consent.
  3. Weight ranging from 20 to 150 kg inclusive.
  4. Are located in a non-ICU hospital setting.
  5. Agree to not eat during the testing period.
  6. Agree to keep still.

Exclusion Criteria:

  1. Are connected to a device which may interfere with the device monitoring in this study.
  2. Are receiving any bedside care which may be incompatible with the study procedures.
  3. Sleep apnea.
  4. Pregnant or breast feeding.
  5. A likely need to receive or undergo a procedure during the testing period.
  6. Cannot accept a nasal cannula, or have a monitor lead placed on the chest.
  7. A significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
  8. Are wearing pacemaker or defibrillator.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03356184


Locations
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United States, Virginia
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States, 23298-0102
Sponsors and Collaborators
Darma Inc.
Virginia Commonwealth University
Investigators
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Principal Investigator: Ava Puccio, RN University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Darma Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] July 7, 2017

More Information
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Responsible Party: Darma Inc.
ClinicalTrials.gov Identifier: NCT03356184    
Other Study ID Numbers: RHEA EL30-2017-006
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No