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

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ClinicalTrials.gov Identifier: NCT03123354
Recruitment Status : Completed
First Posted : April 21, 2017
Results First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Surgery Device: O3 regional oximeter sensor Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children Undergoing Cardiac Catherization
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : March 13, 2017
Actual Study Completion Date : March 13, 2017

Arm Intervention/treatment
Experimental: Test group
All subjects are enrolled in the test group and receive an O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure.
Device: O3 regional oximeter sensor
Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor




Primary Outcome Measures :
  1. Accuracy of Sensor by Arms Calculation of Percent rSO2 [ Time Frame: 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.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients undergoing cardiac catheterization procedure for treatment or diagnosis of cardiovascular disease
  • 1 day to less than 18 years of age
  • Weight between 3.5 and 40 kg
  • Parental or legal guardian consent and subject assent

Exclusion Criteria:

  • Failure to obtain written consent
  • Equal or more than 18 years in age
  • Weight more than 40kg or less than 3.5kg
  • Jaundice with bilirubin levels higher than the reference range
  • Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent motioning of SpO2 levels during the study or placement of cerebral oximeter

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123354


Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Masimo Corporation
  Study Documents (Full-Text)

Documents provided by Masimo Corporation:
Study Protocol  [PDF] December 2, 2014
Statistical Analysis Plan  [PDF] May 9, 2018


Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03123354     History of Changes
Other Study ID Numbers: RAMA0003
First Posted: April 21, 2017    Key Record Dates
Results First Posted: June 13, 2018
Last Update Posted: June 13, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No