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Trial record 2 of 619 for:    oximeter

SpO2 Validation of Noninvasive Red Diamond Disposable Pulse Oximeter Sensor

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ClinicalTrials.gov Identifier: NCT03124602
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : August 22, 2019
Last Update Posted : August 22, 2019
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: Red Diamond Disposable Pulse Oximeter Sensor
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Noninvasive Red Diamond Disposable Pulse Oximeter Sensor
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor
Period Title: Overall Study
Started 35
Completed 25
Not Completed 10
Arm/Group Title Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
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%
[1]
Measure Description: 35 subject were enrolled but only 25 subjects completed the study
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
12
  48.0%
Male
13
  52.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino
8
  32.0%
Not Hispanic or Latino
17
  68.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Accuracy of Red Diamond Disposable Pulse Oximeter Sensor by Arms Calculation
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 Accuracy root mean square (ARMS) error value. In order to obtain the Arms value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter 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 per subject
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls
Hide Arm/Group Description:
All subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: percent of oxygen saturated hemoglobin
1.16
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor
All-Cause Mortality
Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls
Affected / at Risk (%)
Total   0/35 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls
Affected / at Risk (%)
Total   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls
Affected / at Risk (%)
Total   3/35 (8.57%) 
Injury, poisoning and procedural complications   
Dizzy/Lightheaded, Vasovagal *  3/35 (8.57%) 
*
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
Phone: 9492977459
EMail: studies@masimo.com
Layout table for additonal information
Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124602     History of Changes
Other Study ID Numbers: TP18604A_195
First Submitted: April 14, 2017
First Posted: April 24, 2017
Results First Submitted: December 6, 2018
Results First Posted: August 22, 2019
Last Update Posted: August 22, 2019