Clinical trial NCT03257956: Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients
Official title: Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vital Sign Monitoring
Keywords: Vital Sign
Vigilance System
Heart Rate
Respiratory Rate
Lead sponsor: Darma Inc.
Sponsor class: INDUSTRY
Collaborators: name: Tufts Medical Center
First posted: 2017-08-22
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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 hear rate and respiratory rate of the same participant at the same time at 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.
Primary purpose: SCREENING

Brief summary: This study comparing both of the investigational device and reference device to 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 the overall mean root mean square difference (RMSD). Results of the investigational device and reference device compared with the patient monitor are 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, Children HO: μ = 3.5 vs. HA: μ \< 3.5,

The primary hypotheses for RR, are as follows:

Adults HO: μ = 2.25 vs. HA: μ \< 2.25, Children HO: μ = 2.5 vs. HA: μ \< 2.5, 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 contact-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 on 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.

Eligibility 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 breastfeeding.
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.

Primary outcomes:
measure: RMSD of Investigational Device's Heart Rate and Gold Standard Device's heart rate
timeFrame: 30 days
measure: RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory rate
timeFrame: 30 days
Secondary outcomes:
measure: Heart Rate t Test Comparison result between the Investigational Device and the Reference Device
timeFrame: 30 days
measure: Respiratory Rate t Test Comparison result between the Investigational Device and the
timeFrame: 30 days
measure: Motion Notification Accuracy(%)
timeFrame: 30 days
measure: Bed Exit Notification Accuracy(%)
timeFrame: 30 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Judith Cullinane, MSN
role: PRINCIPAL_INVESTIGATOR
References: