Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor

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: NCT03125005
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : June 6, 2017
Last Update Posted : July 27, 2017
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: Rainbow Universal Pulse Oximeter Sensor
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rainbow Universal Pulse Oximeter Sensor
Hide Arm/Group Description

All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.

Rainbow Universal Pulse Oximeter Sensor

Period Title: Overall Study
Started 51
Completed 51
Not Completed 0
Arm/Group Title Rainbow Universal Pulse Oximeter Sensor
Hide Arm/Group Description

All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.

Rainbow Universal Pulse Oximeter Sensor

Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
<=18 years
0
   0.0%
Between 18 and 65 years
51
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
29
  56.9%
Male
22
  43.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants
51
1.Primary Outcome
Title Accuracy of Sensor by Arms Calculation
Hide Description Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.
Time Frame 5 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rainbow Universal Pulse Oximeter Sensor
Hide Arm/Group Description:

All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.

Rainbow Universal Pulse Oximeter Sensor

Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Percentage of total hemoglobin
0.63
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rainbow Universal Pulse Oximeter Sensor
Hide Arm/Group Description

All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.

Rainbow Universal Pulse Oximeter Sensor

All-Cause Mortality
Rainbow Universal Pulse Oximeter Sensor
Affected / at Risk (%)
Total   0/51 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Rainbow Universal Pulse Oximeter Sensor
Affected / at Risk (%)
Total   0/51 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rainbow Universal Pulse Oximeter Sensor
Affected / at Risk (%)
Total   0/51 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Vikram Ramakanth
Organization: Masimo
EMail: clinicalresearchdept@masimo.com
Layout table for additonal information
Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03125005     History of Changes
Other Study ID Numbers: TR22640-BICK0001
First Submitted: April 14, 2017
First Posted: April 24, 2017
Results First Submitted: May 8, 2017
Results First Posted: June 6, 2017
Last Update Posted: July 27, 2017