At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Respiratory Rate Validation Study - Gabi SmartCare Gabi Band
In Brief
A clinical study evaluating Respiratory rate measure based on PPG for Measure Accuracy of Respiratory Rate. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The purpose of this study is to conduct a Respiratory Rate accuracy validation on pediatrics population comparing the Gabi SmartCare Gabi Band to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex- Ohmeda) by manually scoring the collected waveform for data analysis.
Study Details
Timeline
Interventions
Testing was conducted under normal office environment conditions. Each subject was connected to the reference EtCO2 monitor (GE Datex-Ohmeda) and the Device Under Test, the Gabi SmartCare Gabi Band. A waveform collected from an EtCO2 measurement was used to determine performance of respiratory rate metrics. Each subject was given a nasal cannula that allowed for measurement of the EtCO2 respiratory rate. The reference respiratory rate was measured simultaneously with the Device Under Test. Data was marked for stable quiet periods that were useable for analysis.