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NCT05466942
RDS MultiSense® SpO2 Calibration
NA trial testing Pulse Oximeter, Respiratory Rate, Heart Rate in Hypoxia in 16 participants. Completed in 20 October 2022.
17 March 2022
Quick facts
| Lead sponsor | Rhythm Diagnostic Systems |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 16 |
| Start date | 15 March 2022 |
| Primary completion | 17 March 2022 |
| Estimated completion | 20 October 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Pulse Oximeter, Respiratory Rate, Heart Rate
Conditions studied
- Hypoxia — all drugs for Hypoxia →
Sponsor
Rhythm Diagnostic Systems
Who can join
Adults 18 to 50, any sex, with Hypoxia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Data will be collected with the MultiSense® pulse oximetry system during non-motion conditions over the range of 70-100%. A Clinimark reference system, previously correlated to arterial blood CO-Oximetry will be the basis for comparison. A minimum of fifteen (15) up to fifty (50) healthy adult subjects, ranging in pigmentation from light to dark, with at least six (6) subjects with dark pigmentation (Fitzpatrick 5-6), will be enrolled in the study to meet the study design requirements defined by ISO 80601-2-61 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). SpO2 data will be evaluated during non-motion conditions. SpO2 data will be evaluated during stable step plateaus of induced hypoxic levels. The investigational device will be placed on the thorax of the subjects (patch on the upper back and external electrode on the right pectoral). Simultaneous data collection will be set up for the reference and the systems under test.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Accuracy of Rhythm Diagnostic Systems' MultiSense<sup>®</sup> in Detection of Arterial Oxygen Saturation and Respiratory Rate During Hypoxia in Humans: Effects of Skin Color and Device Localization.
Evrard C, El Attaoui A, Pistea C, Enache I, et al · · 2024 · PMID 39796917 · DOI 10.3390/s25010127
Verify or expand the search:
- PubMed search for NCT05466942
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07307560 — High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients · NA · recruiting
- NCT07408388 — Pulse Oximeter Accuracy During Stable Hypoxia Plateaus · active not recruiting
Other Rhythm Diagnostic Systems trials
Trials by the same sponsor.
- NCT07514286 — Assessment of the Feasibility and Organisational Impact of a Care Pathway Incorporating the MultiSense® Medical Device f · NA · not yet recruiting
- NCT05359328 — RDS MultiSense® SpO2 Validation Study · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05466942 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rhythm Diagnostic Systems
- Last refreshed: 19 December 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/NCT05466942.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing