N/A
N=21
Respiratory Rate Validation Study
Measure Accuracy of Respiratory Rate
Bottom Line
View on ClinicalTrials.gov: NCT05856422 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Accuracy of Device Under Test for the Measurement of Respiratory Rate, Measured in Breath/Min — 2.9 breaths/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Respiratory rate measure based on PPG (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Gabi SmartCare
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Device Under Test for the Measurement of Respiratory Rate, Measured in Breath/Min |
2.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Ability of the parent or guardian to understand and provide written informed consent
- Participant is 0 to 12 years of age
- Subjects that are between 7 and 12 years of age must provide Assent to participate in the study
Exclusion Criteria
- Participants evaluated by the Investigator and Clinical Staff and found to be medically unsuitable or have self-reported health conditions that are currently unstable as identified in the Participant Demographics and Screening Record Form
- Participant has injuries, deformities or abnormalities that may prevent proper application of the device under test
- Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self-reported)
Data sourced from ClinicalTrials.gov (NCT05856422). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.