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NCT05856422 · ClinicalTrials.gov registry record
Respiratory Rate Validation Study
A clinical trial, sponsored by Gabi SmartCare.
- Completed
- Registry status
- 24
- Enrollment target
NCT05856422: Completed study, sponsored by Gabi SmartCare.
NCT05856422 is a clinical trial that has completed, run by Gabi SmartCare. The registered enrollment target is 24 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05856422 has completed, sponsored by Gabi SmartCare.
- COMPLETED
- Registry status
- 24 participants
- Enrollment target
Study 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.
Primary Outcome
Arms or rms error, given in breath per minute, is the calculation of root mean square between Respiratory rate of the subject device and the manually scored reference Respiratory Rate EtCO2 waveform, for all stable respiratory periods. It is a way of averaging the absolute values of errors over the full measurement range and is a similar measurement to a "rms error". It indicates how far (accurate) the provided value is from the reference used. A passing result required an Arms of ≤3 breaths/min
Interventions
- DEVICE Respiratory rate measure based on PPG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-12-05 |
| Est. Completion | 2022-12-29 |
What the finished NCT05856422 record still lists
NCT05856422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Respiratory rate measure based on PPG is the first listed.
NCT05856422 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05856422 about?
NCT05856422 is a clinical study titled "Respiratory Rate Validation Study". 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.
What is the current status of trial NCT05856422?
This trial is currently completed. The enrollment target is 24 participants. The study started on 2022-12-05. Estimated completion is 2022-12-29.
What interventions are being tested in trial NCT05856422?
The interventions under investigation include: Respiratory rate measure based on PPG (DEVICE).
Who is sponsoring clinical trial NCT05856422?
This trial is sponsored by Gabi SmartCare, which has 3 total clinical trials registered on ClinicalTrials.gov.
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