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NCT03869840
Accuracy of Detection of Methemoglobin With Pulse Oximetry
trial testing Sensor to spot check blood levels in Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and Methemoglobinemia in 13 participants. Completed in 29 March 2019.
29 March 2019
Quick facts
| Lead sponsor | Nonin Medical, Inc |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 13 |
| Start date | 26 March 2019 |
| Primary completion | 29 March 2019 |
| Estimated completion | 29 March 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Sensor to spot check blood levels
Conditions studied
- Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and Methemoglobinemia — all drugs for Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and Methemoglobinemia →
Sponsor
Nonin Medical, Inc
Who can join
Adults 18 to 50, any sex, with Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and Methemoglobinemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The non-invasive measurement of dysfunctional hemoglobins allows physicians to monitor levels in affected individuals without requiring blood samples or laboratory testing. Nonin Medical Inc, has recently developed a multi-wavelength device that measures carboxyhemoglobin and methemoglobin non-invasively. The primary objective of this study is to validate %MetHb and SpO2 accuracy performance of the study device. Evaluations will be for the range of 0 to 15% MetHb with 95-100% SaO2 as assessed by CO-oximetry, and 0-15% MetHb accuracy under conditions of elevated HHb (SaO2 80-100%) as assessed by CO-oximetry, and SpO2 with 80-100% SaO2 during elevated MetHb as assessed by CO-oximetry.
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:
- PubMed search for NCT03869840
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Nonin Medical, Inc trials
Trials by the same sponsor.
- NCT03604029 — Evaluating the Diagnostic Performance of ACS Using NIRS in Traumatized Lower Extremities · unknown
- NCT03592914 — Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients · completed
- NCT03348189 — SpO2 Hypoxia Accuracy Validation Study · completed
- NCT03223870 — Respiratory Rate Accuracy - Healthy Adults · completed
- NCT03030833 — Dysfunctional Hemoglobin Pulse Oximetry · 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 NCT03869840 (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 Nonin Medical, Inc
- Last refreshed: 8 April 2019
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/NCT03869840.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing