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

NCT ID: NCT03269643

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2017-11-24

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.

Conditions

Vital Sign Monitoring

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Investigational Group

The RHEA device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.

Group Type: EXPERIMENTAL

Investigational Group

Intervention Type: DEVICE

The RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.

Reference Group

The reference device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.

Group Type: ACTIVE_COMPARATOR

Reference group

Intervention Type: DEVICE

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.

Interventions

Investigational Group

The RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: collaborator

Darma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arrel Olano, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

MedStar Health Research Institute, Inc.

Washington D.C., District of Columbia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RHEA EL30-2017-003

Identifier Type: -

Identifier Source: org_study_id