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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Surgery
Intervention Device: O3 regional oximeter sensor
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title O3 Regional Oximeter Sensors
Hide Arm/Group Description

All subjects are enrolled in the test group and receive O3 regional oximeter sensors during their scheduled, general cardiac catheterization procedure.

O3 regional oximeter sensors: Noninvasive sensors are placed on the forehead for measurement of oxygenation in the area under the sensor

Period Title: Overall Study
Started 44
Completed 38
Not Completed 6
Reason Not Completed
Physician Decision             6
Arm/Group Title O3 Regional Oximeter Sensors
Hide Arm/Group Description

All subjects are enrolled in the test group and receive the O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure.

O3 regional oximeter sensor: Noninvasive sensors are placed on the forehead for measurement of oxygenation in the area under the sensor.

Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
The subjects included for the analysis are within the desired calibration range, with no sensor placement issues in the data collection time period.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
0-23 months
14
  42.4%
2-12 years
19
  57.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
15
  45.5%
Male
18
  54.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 33 participants
White
16
  48.5%
Hispanic/Latino
11
  33.3%
Asian
4
  12.1%
Not Hispanic
2
   6.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants
33
1.Primary Outcome
Title Accuracy of Sensor by Arms Calculation of Percent rSO2
Hide Description 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.
Time Frame One visit; up to 4 hours
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title O3 Regional Oximeter Sensors (Test Group)
Hide Arm/Group Description:

All pediatric subjects are enrolled in the test group and receive an O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure.

O3 regional oximeter sensor: Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor

Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: %rSO2
5.0
Time Frame For each subject, adverse event data were collected up to 2 days after subject's single visit participation in the study.
Adverse Event Reporting Description Subjects were observed during the procedure, as well as contacted via phone call up to 2 days after the procedure to gather adverse event information.
 
Arm/Group Title O3 Regional Oximeter Sensors
Hide Arm/Group Description

All subjects are enrolled in the test group and receive an O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure.

O3 regional oximeter sensor: Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor

All-Cause Mortality
O3 Regional Oximeter Sensors
Affected / at Risk (%)
Total   0/44 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
O3 Regional Oximeter Sensors
Affected / at Risk (%) # Events
Total   0/44 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
O3 Regional Oximeter Sensors
Affected / at Risk (%) # Events
Total   2/44 (4.55%)    
Skin and subcutaneous tissue disorders   
Mild rash, localized to sensor location   2/44 (4.55%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Vikram Ramakanth
Organization: Masimo Corporation
Phone: 1 (949) 297-7416
Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03123354     History of Changes
Other Study ID Numbers: RAMA0003
First Submitted: April 14, 2017
First Posted: April 21, 2017
Results First Submitted: March 13, 2018
Results First Posted: June 13, 2018
Last Update Posted: June 13, 2018