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NCT03677375

Hemodilution Validation of INVSENSOR00026

Completed NA Results posted Last updated 20 May 2019
What this trial tests

NA trial testing INVSENSOR00026 in Healthy in 173 participants. Completed in 4 February 2019.

Timeline
4 September 2018
Primary endpoint
4 February 2019
4 February 2019

Quick facts

Lead sponsorMasimo Corporation
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment173
Start date4 September 2018
Primary completion4 February 2019
Estimated completion4 February 2019
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 Noninvasive Hemoglobin Sensor by Arms Calculation Primary · 1-5 hours

Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value 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 and precision is computed as the Arms Error value.

GroupValue95% CI
Test Subject1.13

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Test Subject
Serious: 0/93 (0%)
Deaths: 0/93
Other adverse events (6 terms — click to expand)

ReactionSystemTest Subject
Swelling due to IV catheter site infiltrationInjury, poisoning and procedural complications
Bruising and swelling at arterial siteInjury, poisoning and procedural complications
Vasovagal episode during arterial line placementInjury, poisoning and procedural complications
Numbness secondary to local anesthetic infiltrationInjury, poisoning and procedural complications
HeadacheInjury, poisoning and procedural complications
DiscomfortInjury, poisoning and procedural complications

Data from ClinicalTrials.gov NCT03677375 adverse events section.

Sponsor's own description

In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of a noninvasive hemoglobin sensor will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

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 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/NCT03677375.

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