Respiratory Rate Validation Study

Completed

Conditions studied: Measure Accuracy of Respiratory Rate

In brief

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.

Key facts

Study ID

NCT05856422

Run by

Gabi SmartCare

People needed

24

Starts

2022-12-05

Expected to finish

2022-12-29

Last updated by the study team

2024-11-26

Who can join

Age: any, up to 12. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Clinimark LLC — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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