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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

Tracking Information
First Submitted Date  ICMJE April 14, 2017
First Posted Date  ICMJE April 21, 2017
Results First Submitted Date  ICMJE March 13, 2018
Results First Posted Date  ICMJE June 13, 2018
Last Update Posted Date June 13, 2018
Actual Study Start Date  ICMJE May 1, 2015
Actual Primary Completion Date March 13, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03123354 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children
Official Title  ICMJE Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children Undergoing Cardiac Catherization
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Surgery
Intervention  ICMJE Device: O3 regional oximeter sensor
Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor
Study Arms  ICMJE 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.
Intervention: Device: O3 regional oximeter sensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2017)
44
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 13, 2017
Actual Primary Completion Date March 13, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03123354
Other Study ID Numbers  ICMJE RAMA0003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Masimo Corporation
Study Sponsor  ICMJE Masimo Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Masimo Corporation
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP