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NCT03124602

SpO2 Validation of Noninvasive Red Diamond Disposable Pulse Oximeter Sensor

Completed NA Results posted Last updated 22 August 2019
What this trial tests

NA trial testing Red Diamond Disposable Pulse Oximeter Sensor in Healthy in 35 participants. Completed in 11 May 2017.

Timeline
7 March 2017
Primary endpoint
11 May 2017
11 May 2017

Quick facts

Lead sponsorMasimo Corporation
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment35
Start date7 March 2017
Primary completion11 May 2017
Estimated completion11 May 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Masimo Corporation — full company profile →

Who can join

Adults 18 to 50, any sex, with Healthy. 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 Red Diamond Disposable Pulse Oximeter Sensor by Arms Calculation Primary · 1-5 hours per subject

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 Accuracy root mean square (ARMS) error value. In order to obtain the Arms value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, 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

GroupValue95% CI
Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls1.16

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls
Serious: 0/35 (0%)
Deaths: 0/35
Other adverse events (1 terms — click to expand)

ReactionSystemRed Diamond Disposable Pul…
Dizzy/Lightheaded, VasovagalInjury, poisoning and procedural complications

Data from ClinicalTrials.gov NCT03124602 adverse events section.

Sponsor's own description

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Racial effects on Masimo pulse oximetry: a laboratory study.
    Barker SJ, Wilson WC. · · 2023 · cited 29× · PMID 36370242 · DOI 10.1007/s10877-022-00927-w
  2. Racial effects on masimo pulse oximetry: impact of low perfusion index.
    Sharma V, Barker SJ, Sorci R, Park L, et al · · 2024 · cited 6× · PMID 38238634 · DOI 10.1007/s10877-023-01113-2

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Masimo Corporation trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03124602.

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