Who is sponsoring NCT05856422?

NCT05856422 is sponsored by Gabi SmartCare.

What drugs are being tested in NCT05856422?

Interventions in NCT05856422: Respiratory rate measure based on PPG.

What condition does NCT05856422 study?

NCT05856422 studies Measure Accuracy of Respiratory Rate.

Is NCT05856422 still recruiting?

NCT05856422 is currently completed. Last updated 26 November 2024.

Are results published for NCT05856422?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-11-26 · How we verify

NCT05856422

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Respiratory Rate Validation Study

Completed Results posted Last updated 26 November 2024

What this trial tests

trial testing Respiratory rate measure based on PPG in Measure Accuracy of Respiratory Rate in 24 participants. Completed in 29 December 2022.

Timeline

5 December 2022

Primary endpoint
29 December 2022

29 December 2022

Quick facts

Lead sponsor	Gabi SmartCare
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	24
Start date	5 December 2022
Primary completion	29 December 2022
Estimated completion	29 December 2022
Sites	1 location across United States

Drugs / interventions tested

Respiratory rate measure based on PPG

Conditions studied

Measure Accuracy of Respiratory Rate — all drugs for Measure Accuracy of Respiratory Rate →

Sponsor

Gabi SmartCare

Who can join

Adults 1 Minute to 12, any sex, with Measure Accuracy of Respiratory Rate. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Accuracy of Device Under Test for the Measurement of Respiratory Rate, Measured in Breath/Min Primary · Every 60 seconds, over a total duration of maximum 60 minutes

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.

Group	Value	95% CI
Pediatrics Population	2.9

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Gabi SmartCare trials

Trials by the same sponsor.

NCT05873335 — In Vivo Pulse Oximeter Validation Study · NA · completed
NCT05319236 — Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study) · NA · completed
NCT04886583 — Assessment of the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for Continuous Vital Parameters Monitorin · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05856422 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gabi SmartCare
Last refreshed: 26 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05856422.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing