Under 1 Month, any sex, with Evaluation of SpO2 Performance. 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 Oxygen Saturation (SpO2) Measurement by RMS CalculationPrimary· up to 12 hours
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is co
Group
Value
95% CI
RD SET Neo SpO2
3.5
Sponsor's own description
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the INVSENSOR00024 sensors in the neonatal population in a clinical environment using convenience sampling.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT03570255 — Feasibility and Performance Evaluation for INVSENSOR00024
· NA
· completed
Other Masimo Corporation trials
Trials by the same sponsor.
NCT07223177 — Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric Populations
· NA
· recruiting
NCT07223164 — Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
· NA
· recruiting
NCT06334055 — Validation Study of Mean Arterial Pressure (MAP) Parameter of Masimo INVSENSOR00073
· NA
· completed
NCT06432881 — Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)
· NA
· recruiting
NCT06148623 — Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin Pigmentation
· NA
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Masimo Corporation
Last refreshed: 25 February 2020
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/NCT03831282.