Ignite Creation Date:
2024-05-06 @ 10:26 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03257956
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2017-08-16
Brief Title:
Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients
Sponsor:
Darma Inc
Organization:
Darma Inc
Study Overview
Official Title:
Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients
Status:
COMPLETED
Status Verified Date:
2019-04
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:
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 325 vs HA μ 325 Children HO μ 35 vs HA μ 35
The primary hypotheses for RR are as follows
Adults HO μ 225 vs HA μ 225 Children HO μ 25 vs HA μ 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 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
The primary hypotheses for HR are as follows
Adults HO μ 325 vs HA μ 325 Children HO μ 35 vs HA μ 35
The primary hypotheses for RR are as follows
Adults HO μ 225 vs HA μ 225 Children HO μ 25 vs HA μ 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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None