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

• Sponsor: Masimo Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03123354
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arm: 1
• Actual Duration (Months): 22.4
• Patients Per Site Per Month: 2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: N/A
• 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: Mar 13, 2017
• Actual Study Completion Date: Mar 13, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Accuracy of Sensor by Arms Calculation of Percent rSO2 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

• Masimo Corporation

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Dec 2, 2014
• Statistical Analysis Plan - May 9, 2018

More Information

Publications

None provided.

• Responsible Party: Masimo Corporation
• ClinicalTrials.gov Identifier: NCT03123354
• Other Study ID Numbers: RAMA0003
• First Posted: Apr 21, 2017
• Last Update Posted: Jun 13, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	O3 Regional Oximeter Sensors
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

Baseline Characteristics

Arm/Group Title	O3 Regional Oximeter Sensors
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 Participants	33
Age, Customized (Count of Participants)
0-23 months	14 42.4%
2-12 years	19 57.6%
Sex: Female, Male (Count of Participants)
Female	15 45.5%
Male	18 54.5%
Race/Ethnicity, Customized (Count of Participants)
White	16 48.5%
Hispanic/Latino	11 33.3%
Asian	4 12.1%
Not Hispanic	2 6.1%
Region of Enrollment (participants) [Number]
United States	33 100%

Outcome Measures

1. Primary Outcome

Title	Accuracy of Sensor by Arms Calculation of Percent rSO2
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	O3 Regional Oximeter Sensors (Test Group)
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
Measure Participants	33
Number [%rSO2]	5.0

Adverse Events

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
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 (%)	# Events
Total	0/44 (0%)
Serious Adverse Events
	O3 Regional Oximeter Sensors
	Affected / at Risk (%)	# Events
Total	0/44 (0%)
Other (Not Including Serious) Adverse Events
	O3 Regional Oximeter Sensors
	Affected / at Risk (%)	# Events
Total	2/44 (4.5%)
Skin and subcutaneous tissue disorders
Mild rash, localized to sensor location	2/44 (4.5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.