NCT03257956

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Darma Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Vital Sign Monitoring

Interventions

Type	Name	Description
DEVICE	Investigational Group	The RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
DEVICE	reference 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.

Timeline

• Start date: 2017-08-02
• Primary completion: 2017-09-20
• Completion: 2017-09-20
• First posted: 2017-08-22
• Last updated: 2019-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study