NCT05210712

Respiratory Rate Validation Study - RS001.2 Respiree Cardio-Respiratory Monitor

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Respiree Pte Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the RS001.2 Respiree Cardio-Respiratory Monitor to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda).

Detailed description

After IRB approval, a minimum of 30 volunteer test subjects will be enrolled for the final validation study population. A maximum of 60 subjects will be enrolled. All subjects will be 18 or older and selected to represent a range of body types including small, average, muscular, and large with a range of BMI's. Each subject will be connected to a commonly used End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and the RS001.2 Respiree Cardio-Respiratory Monitor. The end tidal carbon dioxide (EtCO2) monitor will determine performance of respiratory rate metrics (Reference). Each subject will be instrumented with a mouthpiece or nasal cannula that allows for measurement of the EtCO2. Subjects will also be connected to a 3-lead ECG and pulse oximeter in order to monitor the subject's vital signs for safety purposes. Subjects will be seated for the study. A range of stable respiratory rates will be elicited from each volunteer test subject. After a baseline data set at the subject natural respiratory rate, the rates will be approximately 5, 10, 15, 20, 25, 30, 35, 40, 45, and 50 breaths per minute; with some natural variation from these exact numbers and tailored to the subject's capabilities. A paced breathing app will be used. It is expected that some of the subjects may not be able to be evaluated over the entire range as some subjects may not be able to breathe at the lower and higher respiratory rates. In this case, additional data may be recorded at the baseline range and other ranges that are comfortable for the subject. Once stable breathing at specified rate is achieved data will be collected for one to three minutes per respiratory rate plateau. Between plateaus, the subjects using a mouthpiece are allowed to take the mouthpiece out and relax. The respiratory rate will be measured simultaneously with the Reference and the Device Under Test. During the stable plateaus at each level, the data will be averaged in approximately 60 second intervals. For final validation, the Reference EtCO2 waveform will be scored by counting the respiratory peaks per minute. The Accuracy root-mean-square (Arms) will be the basis for evaluation and acceptance. To 'Pass' this test the RS001.2 Respiree Cardio-Respiratory Monitor (Device Under Test) must demonstrate an Accuracy root-mean-square (Arms) of ≤3 breaths per minute when compared to the Reference EtCO2 monitor.

Conditions

• A Minimum of 30 Adults, Ages 18 Years and Older

Interventions

Type	Name	Description
DEVICE	RS001.2 Respiree Cardio-Respiratory Monitor	The RS001.2 Respiree Cardio-Respiratory Monitor is intended as a noninvasive multiparameter monitor on the adult population

Timeline

• Start date: 2022-01-24
• Primary completion: 2022-02-10
• Completion: 2022-02-10
• First posted: 2022-01-27
• Last updated: 2022-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study