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Accuracy of Oxygen Saturation (SpO2) Noninvasive Pulse Oximeter Sensor (RD Disposable) Under Motion Conditions

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ClinicalTrials.gov Identifier: NCT03124784
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : March 23, 2018
Last Update Posted : March 23, 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 Healthy
Intervention Device: RD Disposable Sensors
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RD Disposable Sensors
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
Period Title: Overall Study
Started 27
Completed 25
Not Completed 2
Reason Not Completed
Adverse Event             1
Computer/Equip Malfunction             1
Arm/Group Title RD Disposable Sensors
Hide Arm/Group Description

All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors

RD Disposable Sensors: Noninvasive pulse oximeter sensor

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
13
  52.0%
Male
12
  48.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
African American
7
  28.0%
Asian or Pacific Islander
4
  16.0%
Caucasian
7
  28.0%
Hispanic
7
  28.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
 100.0%
1.Primary Outcome
Title SpO2 ARMS of Sensor Under Motion Conditions
Hide Description Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Time Frame 1-5 hours
Hide Outcome Measure Data
Hide Analysis Population Description
2 subjects were excluded from data analysis: one due to adverse event and the other due to equipment malfunction.
Arm/Group Title RD Disposable Sensors
Hide Arm/Group Description:
All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: % of oxygen saturated hemoglobin
1.31
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RD Disposable Sensors
Comments Accuracy Root Mean Square (ARMS)
Type of Statistical Test Equivalence
Comments ARMS<= 3 %SpO2 Error per International Organization For Standardization (ISO) -80601-2-61 Pilot study Monte Carlo simulation provided 80% Power with 25 subjects for an expected ARMS< 3 % SpO2.
Method of Estimation Estimation Parameter ARMS
Estimated Value 0
Estimation Comments [Not Specified]
Other Statistical Analysis Per ISO-80601-2-61, the Root Mean Square difference (SpO2-SaO2) is the measure of merit for desaturation studies.
Time Frame Adverse event data was collected over the course of the study (within 1 month).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RD Disposable Sensors
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
All-Cause Mortality
RD Disposable Sensors
Affected / at Risk (%)
Total   0/27 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
RD Disposable Sensors
Affected / at Risk (%) # Events
Total   0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RD Disposable Sensors
Affected / at Risk (%) # Events
Total   2/27 (7.41%)    
General disorders   
Irregular heart rate *  1/27 (3.70%)  1
Injury, poisoning and procedural complications   
Sensitivity at site of arterial line placement *  1/27 (3.70%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tala Harake
Organization: Masimo Corporation
Phone: 949-297-7000
EMail: studies@masimo.com
Layout table for additonal information
Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124784     History of Changes
Other Study ID Numbers: TR33143-000190A
First Submitted: April 14, 2017
First Posted: April 24, 2017
Results First Submitted: January 19, 2018
Results First Posted: March 23, 2018
Last Update Posted: March 23, 2018