NCT03123354

Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children

Completed NA Results posted Last updated 13 June 2018

What this trial tests

NA trial testing O3 regional oximeter sensor in Surgery in 44 participants. Completed in 13 March 2017.

Timeline

1 May 2015

Primary endpoint
13 March 2017

13 March 2017

Quick facts

Lead sponsor	Masimo Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	44
Start date	1 May 2015
Primary completion	13 March 2017
Estimated completion	13 March 2017
Sites	1 location across United States

Drugs / interventions tested

• O3 regional oximeter sensor

Conditions studied

• Surgery — all drugs for Surgery →

Sponsor

Masimo Corporation — full company profile →

Who can join

Adults 1 Day to 18, any sex, with Surgery. 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 Sensor by Arms Calculation of Percent rSO2 Primary · One visit; up to 4 hours

The continuous measurements of regional oxygen saturation (rSO2) was compared against its reference cerebral oxygen saturation which is measured by a combination of arterial and jugular venous blood oxygen saturation. Absolute accuracy was determined by the root-mean-squared error (Arms). The Arms error value is calculated as the square root of the sum of the squares of mean bias and estimated standard deviation of bias. The bias is defined as the difference of the rSO2 and its blood reference.

Group	Value	95% CI
O3 Regional Oximeter Sensors (Test Group)	5.0

Adverse events — posted to ClinicalTrials.gov

Time frame: For each subject, adverse event data were collected up to 2 days after subject's single visit participation in the study.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

O3 Regional Oximeter Sensors

Serious: 0/44 (0%)

Deaths: 0/44

Other adverse events (1 terms — click to expand)

Reaction	System	O3 Regional Oximeter Sensors
Mild rash, localized to sensor location	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03123354 adverse events section.

Sponsor's own description

The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.